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
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2024-11-22
2028-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group A: SHR-A1904
SHR-A1904
SHR-A1904
Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
Paclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan
Interventions
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SHR-A1904
SHR-A1904
Paclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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SHR-A1904-302
Identifier Type: -
Identifier Source: org_study_id