Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06649292

SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-12-12

524

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients

CONDITIONS

Official Title

SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years old (including boundary values)
  • Volunteered and signed informed consent
  • ECOG performance status of 0 or 1
  • Expected survival of at least 3 months
  • Diagnosed with gastric or gastroesophageal junction adenocarcinoma
  • Positive Claudin18.2 expression in tumor tissue
  • At least one measurable or evaluable lesion per RECIST 1.1 criteria
  • Adequate bone marrow and organ function
Not Eligible

You will not qualify if you...

  • Received chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before first study dose
  • HER2 positive (IHC 3+ or IHC 2+/ISH +)
  • Toxicities from previous anticancer therapy not recovered to CTCAE 5.0 Grade 1 or lower
  • Presence of leptomeningeal metastasis or active brain metastases
  • History of gastrointestinal perforation, fistula, or unstable gastrointestinal bleeding
  • History of severe cardiovascular or cerebrovascular diseases
  • Any other condition deemed unsuitable for participation by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

Loading map...

Research Team

Q

Qi Shi

CONTACT

L

Liang Hu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here