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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1904, Paclitaxel, Docetaxel, Irinotecan.
- Who it may be relevant to
- Registry conditions: Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Overview
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
Interventions
- Drug SHR-A1904
SHR-A1904 - Drug Paclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan
Primary outcome measures
- Overall Survival [Time frame: Until death, assessed up to approximately 2 years]
Secondary outcome measures (5)
- Progression-free survival (PFS) by investigator assessment [Time frame: Until progression or death, assessed up to approximately 1 year]
- Objective response rate (ORR) by investigator assessment [Time frame: Until progression, assessed up to approximately 1 year]
- Duration of response (DOR) by investigator assessment [Time frame: Until progression or death, assessed up to approximately 1 year]
- Disease control rate (DCR) by investigator assessment [Time frame: Until progression, assessed up to approximately 1 year]
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Time frame: until to 90 days after the last dose，assessed up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Age 18 to 75 years old (including boundary values)
- Volunteer to participate in this clinical study and sign informed consent;
- ECOG score 0-1;
- Expected survival ≥3 months;
- Gastric or Gastroesophageal Junction Adenocarcinoma;
- positive CLDN18.2 expression in tumor tissue;
- There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
- Adequate bone marrow and organ function.
Exclusion criteria
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
- HER2 posotive (IHC 3+ or IHC 2+/ISH +);
- Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
- Individuals with Leptomeningeal metastasis or Active brain metastases;
- Individuals with a history of GI perforation or fistula, unstable GI bleeding;
- Individuals with a history of severe cardiovascular and cerebrovascular diseases;
- The researcher determined that there are other situations that are not suitable for participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06649292 · SHR-A1904-302