Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07709767
PHASE2

Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.

Official title: A Single-Arm, Exploratory Study of Retlirafusp Alfa Plus Chemotherapy as Conversion Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-08-30

Completion Date

2032-08-30

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Retlirafusp Alfa

Retlirafusp alfa 1800 mg will be administered by intravenous infusion on Day 1 of each 21-day cycle. When administered with chemotherapy, retlirafusp alfa will be given first, followed by chemotherapy after an interval of at least 30 minutes.

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1-14 of each 21-day cycle. Interventi

PROCEDURE

Radical Surgery

Participants who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery 4 to 6 weeks after the last dose of preoperative treatment.