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Trial 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
NCT ID:
NCT06649292
Condition:
Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Docetaxel
Irinotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1904
Description:
SHR-A1904
Arm group label:
Treatment group A: SHR-A1904
Intervention type:
Drug
Intervention name:
Paclitaxel, Docetaxel, Irinotecan
Description:
Paclitaxel, Docetaxel, Irinotecan
Arm group label:
Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
Summary:
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected
treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 to 75 years old (including boundary values)
2. Volunteer to participate in this clinical study and sign informed consent;
3. ECOG score 0-1;
4. Expected survival ≥3 months;
5. Gastric or Gastroesophageal Junction Adenocarcinoma;
6. positive CLDN18.2 expression in tumor tissue;
7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1
criteria;
8. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological
therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of
the study
2. HER2 posotive (IHC 3+ or IHC 2+/ISH +);
3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0
Grade≤1;
4. Individuals with Leptomeningeal metastasis or Active brain metastases;
5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;
6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;
7. The researcher determined that there are other situations that are not suitable for
participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Investigator:
Last name:
Ruihua Xu
Email:
Principal Investigator
Start date:
November 10, 2024
Completion date:
March 20, 2028
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06649292
