NCT04202484

Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Gastric and Gastroesophageal Junction Adenocarcinoma

A Prospective, Single-arm, Exploratory Clinical Research on the Efficacy and Safety of Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim population is histopathologically confirmed locally unresectable advanced recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and teggio (SOX) in first-line treatment of unreactable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma. Every 21 days is a cycle, and treatment is scheduled for 6 cycles. Chemotherapy drugs until disease progression, toxicity intolerance, the start of new anti - tumor treatment, withdrawal, loss of access or death, etc., already reached first, shall be the basis for termination. Treatment was effective for more than 6 treatment cycles and toxicity was, the subjects were judged by the researchers when to terminate the treatment and adjust the follow-up treatment plan. For disease progression, toxicity intolerance, and initiation of new antitumor therapies. For subjects who donot reach terminal events such as treatment, withdrawal, loss of follow-up or death, at the end of chemotherapy , the follow-up maintenance regimen was adjusted according to the researchers' evaluation. The screening period of the study was 14 days. The screening test was completed and the evaluation was completed. Subjects with standard discharge entered the treatment period, and the frequency of administration was determined according to the protocol. Conduct treatment and complete relevant tests and assessments before each administration. Tumor imaging was assessed every 6 weeks (±7 days) and all subjects were treated. At the end of the visit, safety and imaging evaluations should be completed. Complete follow-up was conducted for a total of 90 days. Continue to receive tumor evaluation and imaging at a frequency of 2-3 months. Evaluation until disease progression, new antitumor therapy, withdrawal, Lost or dead, etc.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules	Toripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-02-01
• Completion: 2023-02-01
• First posted: 2019-12-17
• Last updated: 2019-12-17