NCT04202484

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

Status unknown Phase 2 Last updated 17 December 2019

What this trial tests

Phase 2 trial testing Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules in Gastric Cancer in 20 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
1 February 2022

1 February 2023

Quick facts

Lead sponsor	RenJi Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 February 2020
Primary completion	1 February 2022
Estimated completion	1 February 2023

Drugs / interventions tested

• Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

RenJi Hospital

Who can join

Adults 18 to 80, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predictive biomarkers and new developments of immunotherapy in gastric cancer: a 2023 update.
   Nie Y, Zhao W, Lu L, Zhou F. · · 2023 · cited 16× · PMID 37559976
2. How to Best Exploit Immunotherapeutics in Advanced Gastric Cancer: Between Biomarkers and Novel Cell-Based Approaches.
   Ghidini M, Petrillo A, Botticelli A, Trapani D, et al · · 2021 · cited 9× · PMID 33915839 · DOI 10.3390/jcm10071412
3. Recent advances in the progress of immune checkpoint inhibitors in the treatment of advanced gastric cancer: A review.
   Shen J, Wang Z. · · 2022 · cited 8× · PMID 36505771 · DOI 10.3389/fonc.2022.934249