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A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06341335 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2024-06-24

No results posted yet for this study

Summary

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.

Conditions

  • Gastric and Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

cadonilimab

iv, q3w

DRUG

pulocimab

iv, q3w

DRUG

paclitaxel

iv, q3w

DRUG

placebo

iv, q3w

Sponsors & Collaborators

Principal Investigators

  • Lin Shen, MD · Peking University Cancer Hospital & Institute

  • Xiaotian Zhang, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-11-30
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT06341335 on ClinicalTrials.gov