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

NCT07770113 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770113 on ClinicalTrials.gov