Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.

Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.

300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

Telatinib

1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).

130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.

Placebos

Peng Wang, M.S.

Jie Li, M.S.

Jin Li, M.D.

Tian Shu Liu, M.D.

The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.

This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter trial in patients with advanced HER2 negative adenocarcinoma of the stomach or Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant therapy, or is unresectable or metastatic at time of first diagnosis. a total of approximately 90 patients will be enrolled and randomized into Telatinib combined with Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be treated until progressive disease (radiologically documented or symptomatic deterioration) or the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.

Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer

A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.

Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks

the proportion of patients who had a best response rating of complete response, partial response, or stable disease

Spots Global Cancer Trial Database for telatinib

Every month we try and update this database with for telatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for telatinib

Every month we try and update this database with for telatinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for telatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.