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Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
CAS Number
154361-50-9
Unique Ingredient Identifier
6804DJ8Z9U
Background

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Indication

Capecitabine is indicated as treatment for a variety of cancer types. For colorectal cancer, capecitabine is indicated as a single agent or a component of a combination chemotherapy regiment for the adjuvant treatment of stage III colon cancer and treatment unresectable or metastatic colorectal cancer. It can also be used as a part of a combination chemotherapy perioperative treatment of adult locally advanced rectal cancer. For breast cancer, capecitabine is indicated for advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated or as a regimen with docetaxel after disease progression on prior anthracycline-containing chemotherapy. For gastric, esophageal, or gastroesophageal junction (GEJ) cancer, capecitabine is indicated as a component of a combination chemotherapy treatment for the treatment of adult unresectable or metastatic gastric, esophageal, or GEJ cancer or adult HER2-overexpressing metastatic gastric or GEJ adenocarcinoma who have not received prior treatment for metastatic disease. Finally, for pancreatic cancer, capecitabine is indicated as adjuvant treatment for adult pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Associated Conditions
Advanced or Metastatic Breast Cancer, Carcinoma of Gallbladder, Cholangiocarcinoma, Hepatocellular Carcinoma, Locally Advanced Rectal Cancer (LARC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Gastric Cancers, Metastatic Neuroendocrine Tumors, Pancreatic Adenocarcinoma, Pancreatic Cancer, Advanced or Metastatic, Platinum-resistant Epithelial Ovarian Cancer, Refractory Fallopian Tube Carcinoma, Stage III Colon Cancer, Unresectable or Metastatic Colorectal Cancer, Metastatic pancreatic endocrine carcinoma, Refractory peritoneal cancer, Refractory, metastatic Colorectal carcinoma, Unresectable, metastatic Esophageal Cancer, Unresectable, metastatic Gastric Cancer, Unresectable, metastatic Gastroesophageal Junction Cancer
Associated Therapies
Chemotherapy

Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Phase 2
Active, not recruiting
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2018-11-28
Last Posted Date
2023-11-09
Lead Sponsor
National Cancer Center, Korea
Target Recruit Count
284
Registration Number
NCT03756298
Locations
🇰🇷

Korea University, Guro hospital, Seoul, Korea, Republic of

Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2018-11-19
Last Posted Date
2023-03-01
Lead Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Target Recruit Count
650
Registration Number
NCT03745170
Locations
🇨🇳

The Fifth Medical Center,Chinese PLA General Hospital, Beijing, Beijing, China

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

First Posted Date
2018-11-07
Last Posted Date
2024-04-11
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
557
Registration Number
NCT03734029
Locations
🇨🇳

Anhui Provincial Hospital, Hefei, Anhui, China

🇨🇳

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

🇨🇳

Jilin Cancer Hospital, Chang chun, Jilin, China

and more 205 locations

Bevacizumab Plus Capecitabin vs S-1 as Maintenance Treatment Following First-line Chemotherapy in the Patients With Advanced Colorectal Adenocarcinoma

Phase 3
Withdrawn
Conditions
Colorectal Adenocarcinoma
Interventions
First Posted Date
2018-10-17
Last Posted Date
2021-03-08
Lead Sponsor
Fujian Cancer Hospital
Registration Number
NCT03708536
Locations
🇨🇳

Rongbo Lin, Fuzhou, Fujian, China

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Phase 2
Conditions
Locally Advanced Rectal Cancer
Interventions
First Posted Date
2018-10-11
Last Posted Date
2019-01-23
Lead Sponsor
Fudan University
Target Recruit Count
160
Registration Number
NCT03702985
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy

Phase 2
Not yet recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2018-09-26
Last Posted Date
2018-09-26
Lead Sponsor
Shandong Cancer Hospital and Institute
Target Recruit Count
200
Registration Number
NCT03684863

A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC

Phase 2
Conditions
Head and Neck Neoplasms
Interventions
First Posted Date
2018-09-19
Last Posted Date
2018-09-19
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
180
Registration Number
NCT03678649
Locations
🇨🇳

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

First Posted Date
2018-09-18
Last Posted Date
2024-12-02
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1579
Registration Number
NCT03675737
Locations
🇨🇷

CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001), San Jose, Costa Rica

🇨🇷

Policlinico San Bosco ( Site 3002), San Jose, Costa Rica

🇨🇷

ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000), San Jose, Costa Rica

and more 212 locations

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase 3
Active, not recruiting
Conditions
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Interventions
First Posted Date
2018-08-31
Last Posted Date
2024-10-03
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
507
Registration Number
NCT03653507
Locations
🇺🇸

Parkland Hospital, Dallas, Texas, United States

🇺🇸

University of Kansas Cancer Center and Medical Pavilion, Fairway, Kansas, United States

🇵🇹

Site PT35109, Braga, Portugal

and more 162 locations

SHR-1210 in Combination With BP102 and XELOX in Patient With Metastatic Colorectal Cancer

Phase 2
Terminated
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2018-08-24
Last Posted Date
2019-05-10
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
12
Registration Number
NCT03645876
Locations
🇨🇳

Cancer Center of Sun-Yat Sen University (CCSYSU), Guangzhou, Guangdong, China

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