A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

Recruiting Phase 3 Interventional Study
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
760 (estimated)
Sponsor
Akeso · Industry
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About This Trial

This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 3. Has lif…
Contacts

Zhifang Yao, MD

86-0760-89873999

clinicaltrials@akesobio.com

CONTACT

Jiafu Ji, MD

jijiafu@hsc.pku.edu.cn

CONTACT