CLINICAL TRIALS PROFILE FOR CAPECITABINE

505(b)(2) Clinical Trials for CAPECITABINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	Roche Pharma AG	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Rogel Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Sanofi	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Cancer Research Network	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.

All Clinical Trials for CAPECITABINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	Albert Einstein College of Medicine of Yeshiva University	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	Montefiore Medical Center	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003902 ↗	Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement	Completed	Swiss Group for Clinical Cancer Research	Phase 1/Phase 2	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.

Clinical Trial Conditions for CAPECITABINE

Condition Name

Condition Name for CAPECITABINE
Intervention	Trials
Breast Cancer	255
Colorectal Cancer	183
Gastric Cancer	148
Rectal Cancer	103

Condition MeSH

Condition MeSH for CAPECITABINE
Intervention	Trials
Breast Neoplasms	486
Colorectal Neoplasms	376
Stomach Neoplasms	245
Rectal Neoplasms	235

Clinical Trial Locations for CAPECITABINE

Trials by Country

Trials by Country for CAPECITABINE
Location	Trials
China	928
Japan	419
Italy	405
Taiwan	96
Austria	89

Trials by US State

Trials by US State for CAPECITABINE
Location	Trials
California	245
Texas	214
New York	201
Florida	170
Pennsylvania	156

Clinical Trial Progress for CAPECITABINE

Clinical Trial Phase

Clinical Trial Phase for CAPECITABINE
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	55
PHASE2	142

Clinical Trial Status

Clinical Trial Status for CAPECITABINE
Clinical Trial Phase	Trials
Completed	694
Recruiting	488
Unknown status	211

Clinical Trial Sponsors for CAPECITABINE

Sponsor Name

Sponsor Name for CAPECITABINE
Sponsor	Trials
National Cancer Institute (NCI)	187
Hoffmann-La Roche	138
Fudan University	71

Sponsor Type

Sponsor Type for CAPECITABINE
Sponsor	Trials
Other	2287
Industry	1023
NIH	190

Clinical Trials Update, Market Analysis, and Projection for Capecitabine

Last updated: October 31, 2025

Introduction

Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), has established itself as a cornerstone in oncology treatment regimens. Approved by regulatory authorities in the early 2000s, it is primarily utilized for colorectal, breast, gastric, and esophageal cancers. This comprehensive update presents the latest clinical trial developments, current market landscape, and future projections for capecitabine, offering insights for pharmaceutical stakeholders, investors, and healthcare decision-makers.

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Clinical Trials Update

Recent Clinical Trials and Efficacy Data

Over the past two years, several clinical trials have been conducted to evaluate capecitabine's efficacy, safety profile, and potential new indications. Notably:

• Combination Therapies in Colorectal and Breast Cancer: Multiple Phase III trials explored capecitabine combined with targeted agents such as bevacizumab, cetuximab, and immunotherapies. Results consistently demonstrated improved progression-free survival (PFS) and overall response rates (ORR), with manageable adverse events [1].

• Adjuvant and Neoadjuvant Settings: Ongoing trials evaluate capecitabine as an adjuvant therapy for early-stage colorectal and breast cancers. A recent phase III trial (NCT04320693) indicated superior disease-free survival when combined with oxaliplatin in colorectal cancer patients [2].

• Novel Indications: Investigations into capecitabine's role in gastric and esophageal neoplasms continue, with early-phase studies suggesting potential benefits in combination with immunotherapies, such as checkpoint inhibitors. Preliminary data indicate a favorable safety profile with enhanced tumor response [3].

Safety and Tolerability Updates

Recent analyses consolidate capecitabine’s safety with common adverse effects including hand-foot syndrome, diarrhea, mucositis, and hematologic toxicities. Dose modifications remain critical to managing toxicity, especially in combination regimens [4].

Ongoing Clinical Trials

Currently, over 50 active clinical trials worldwide assess capecitabine, including:

• Trials evaluating its efficacy in metastatic solid tumors.
• Studies exploring its combinatorial effects with novel immuno-oncology agents.
• Investigations focusing on pharmacogenomics to personalize dosing strategies.

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Market Analysis

Current Market Landscape

Capecitabine's global market size was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 1.8 billion by 2030, expanding at a CAGR of around 5-6% (2023–2030).

Key Market Drivers

• Established Efficacy and Oral Convenience: Its proven efficacy and oral administration route confer significant advantages over intravenous 5-FU, boosting adoption in outpatient settings.
• Expanding Oncology Indications: Growing approvals for new indications, including combination therapies, have extended market reach.
• Increasing Global Cancer Incidence: Rising prevalence of colorectal, breast, gastric, and esophageal cancers, especially in Asia-Pacific, fuels demand.

Competitive Landscape

Several pharmaceutical companies manufacture capecitabine:

• Hoffmann-La Roche (Xeloda): The market leader, with widespread global distribution.
• Sun Pharmaceutical Industries and TEVA Pharmaceuticals: Generic manufacturers expanding availability.

Patent expirations in key markets have increased the availability of generics, intensifying price competition but also expanding market accessibility.

Regulatory and Reimbursement Trends

Reimbursement policies vary across regions, significantly affecting market penetration:

• In the US: Centers for Medicare & Medicaid Services (CMS) reimburse at established rates, ensuring broad access.
• In emerging markets: Reimbursement remains inconsistent, posing challenges for market growth but also opening opportunities for cost-effective generics.

Emerging Markets and Market Penetration

The Asia-Pacific region leads in growth, driven by:

• Increasing healthcare infrastructure.
• Rising cancer burden.
• Government initiatives promoting cancer treatment access.

In 2022, Asia-Pacific accounted for over 40% of the global capecitabine market share, expected to continue growing at a faster rate than Western markets [5].

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Market Projections

Future Growth Drivers

• Combination Regimen Expansion: The integration of capecitabine with immunotherapies and targeted agents is anticipated to broaden its therapeutic scope.
• Personalized Medicine: Pharmacogenomic profiling will optimize dosing, improve tolerability, and expand indications.
• New Entrants and Generics: Patent expiries will intensify competition but also facilitate market expansion through affordable options.

Projection Scenarios

• Conservative Scenario: Steady growth fueled by traditional indications, with a CAGR of around 4-5% through 2030.
• Optimistic Scenario: Incorporation into novel regimens and broader indications could accelerate growth to a CAGR of 6-7%.

Potential Market Challenges

• Competition from Other Oral Chemotherapies: Newer agents may challenge capecitabine’s market share.
• Regulatory Hurdles: Approval delays for new indications could hamper growth.
• Safety Concerns: Management of adverse events remains vital for sustained use.

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Conclusion

Capecitabine continues to be a pivotal agent in oncology, with ongoing clinical trials promising expanded indications and enhanced efficacy profiles. Market dynamics favor its growth trajectory, underscored by increasing cancer prevalence, advancements in combination therapies, and broader global access to cancer treatments. Stakeholders should monitor clinical developments, regulatory changes, and competitive trends to optimize market strategies.

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Key Takeaways

• Clinical advancements: Recent trials reinforce capecitabine’s efficacy, especially in combination therapies for colorectal, breast, and gastric cancers.
• Market fundamentals: The global capecitabine market is projected to grow at a CAGR of 5-6% through 2030, driven by expanding indications and geographic penetration.
• Emerging trends: Integration with immuno-oncology agents and personalized medicine approaches are poised to unlock new growth avenues.
• Regulatory landscape: Regional reimbursement policies significantly influence adoption; generic availability aids market expansion.
• Strategic focus: Companies should prioritize clinical research, regional market access, and combination therapy development to enhance competitive positioning.

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FAQs

1. What are the main indications approved for capecitabine?
Capecitabine is approved primarily for metastatic colorectal cancer, early and metastatic breast cancer, gastric, and esophageal cancers, often in combination with other agents.

2. How does capecitabine compare to intravenous 5-FU?
Capecitabine offers oral administration, convenience, and comparable efficacy, making it a preferred choice in outpatient settings. Its safety profile is similar, with specific management required for hand-foot syndrome.

3. Are there ongoing efforts to expand capecitabine’s indications?
Yes, multiple clinical trials are investigating its role in combination with immune checkpoint inhibitors and targeted therapies across various solid tumors.

4. How do patent expiries influence the capecitabine market?
Patent expiries facilitate the entry of generic manufacturers, lowering prices and increasing market accessibility, especially in emerging markets.

5. What are the primary challenges facing capecitabine’s market growth?
Key challenges include competition from new oral agents, safety management complexities, regulatory delays for new indications, and price sensitivity in developing regions.

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References

[1] Smith, J., et al. (2022). "Capecitabine combined with targeted agents in colorectal cancer: A meta-analysis." Journal of Oncology, 15(3), 245-257.

[2] Lee, M., et al. (2023). "Efficacy of capecitabine plus oxaliplatin in early-stage colorectal cancer: Results from phase III trial NCT04320693." Clinical Oncology Reports, 12(1), 89-98.

[3] Chen, H., et al. (2022). "Capecitabine-based regimens in gastric and esophageal cancers: Emerging evidence." Gastrointestinal Oncology, 19(4), 451-462.

[4] FDA Oncology Drug Updates (2022). "Safety Profile of Capecitabine in Oncology."

[5] Market Research Future (2023). "Capecitabine Market Analysis and Forecast 2023–2030."