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RECRUITING
NCT07770113
PHASE2

A Random, Non-controlled, Open Clinical Study of Apatinib Mesylate Combined With Albumin-bound Paclitaxel ± Adebrelimab in Treating Advanced Second-line Gastric Cancer

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

Summary

This study is a prospective, randomized, non-controlled, open-label clinical trial aimed at evaluating the efficacy and safety of adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel, as well as apatinib mesylate combined with albumin-bound paclitaxel, in treating advanced second-line gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. The study's primary endpoint is median progression-free survival (mPFS), and it plans to enroll 50 patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed first-line systemic therapy. This is a randomized, non-controlled, open-label trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel (Cohort 1) or apatinib mesylate combined with albumin-bound paclitaxel (Cohort 2). The screening phase is 28 days. After completing screening tests and assessments, eligible participants will be randomly assigned to the following treatments: Cohort 1: * Adebrelimab: 1200 mg, IV infusion, once every 21 days, until PD or intolerance, maximum use 2 years; * Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years; * Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles. Cohort 2: * Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years; * Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-06-30

Completion Date

2027-11-30

Last Updated

2026-08-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adebrelimab

Adebrelimab:1200mg, IV infusion, given once every 21 days, until PD or intolerance, for up to 2 years;

DRUG

Apatinib

Apatinib:250mg, taken orally, once a day, days 1-21; continue until PD or intolerance, up to a maximum of 2 years;

DRUG

Albumin-bound paclitaxel

Albumin-bound paclitaxel:200-260 mg/m², intravenous infusion, on day 1, given once every 21 days, for 4-6 cycles.

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China