QLS31905 plus CAPOX vs sintilimab plus CAPOX as first-line treatment for gastric/GEJ cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter phase III study comparing two first-line regimens for gastric or gastroesophageal junction adenocarcinoma. Eligible patients will have CLDN18.2-positive tumors, PD-L1 CPS < 5, and HER2-negative disease, and no prior systemic therapy for unresectable or metastatic disease. Participants will receive either QLS31905 with CAPOX or sintilimab with CAPOX, with outcomes and safety monitored across centers. The study aims to determine which combination provides better efficacy and tolerability in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects voluntarily participate in the study and sign the informed consent form;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Expected survival time ≥ 12 weeks;
* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma;
* No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
* Has measurable or non-measurable (but assessable) disease;
* Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria:

* Known history of allergy to any component of the study drug;
* Other second primary malignant neoplasm within 5 years;
* Significant cardiovascular and cerebrovascular disorders within 6 months before randomization;
* Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation;
* Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc;
* Previous treatment targeting CLDN18.2;
* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Lin Shen, PhD
• Email: doctorshenlin@sina.cn
• Phone: 010-88196358

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tafolecimab with chemoimmunotherapy as neoadjuvant treatment for locally advanced colon cancer

  This study tests whether adding tafolecimab to a chemoimmunotherapy regimen helps shrink locally advanced colon cancer before surgery in adults who have pMMR/MSS tumors.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT07840677

• Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

  This study tests whether adding irreversible electroporation to lenvatinib and sintilimab can help patients with unresectable advanced hepatocellular carcinoma see bigger tumor shrinkage and become eligible for surgery.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China · NCT07832006

• Sintilimab with NALIRIFOX or GP as first-line treatment for metastatic biliary tract cancer

  This study tests whether adding sintilimab to either NALIRIFOX or gemcitabine‑cisplatin can help people with metastatic biliary tract cancer who have not had prior systemic therapy.

  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07831993

• Liposomal irinotecan with 5-FU/LV and sintilimab plus SBRT for unresectable biliary tract cancer

  This trial tests whether combining liposomal irinotecan, 5-FU/LV, and sintilimab, followed by SBRT, can help patients with unresectable locally advanced biliary tract cancer become eligible for surgery or slow disease progression.

  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07797816

• Sintilimab Plus Hypofractionated Radiotherapy Then Chemoradiotherapy for Locally Advanced Head and Neck Cancer

  This study tests whether giving sintilimab with a short, high-dose radiotherapy course followed by standard chemoradiotherapy helps people with locally advanced head and neck squamous cell carcinoma.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07781072

• Bevacizumab, sintilimab, cetuximab and irinotecan in refractory RAS wild-type metastatic colorectal cancer

  This trial tests whether adding sintilimab to a cetuximab and irinotecan backbone, with or without bevacizumab, helps patients with heavily pretreated metastatic colorectal cancer that has RAS wild-type tumors.

  Recruiting Phase 2 Guangdong Provincial People's Hospital · Guangzhou, Guangdong · NCT07722754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.