Last updated: August 20, 2021
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Stomach Cancer
Gastric Ulcers
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT04615312
CRC-PANC-IIT-SHR6390-SHR7390
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-75 years;
- ECOG score ≤ 1;
- Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed byhistology or cytology and imaging diagnosis;
- According to Recist1.1, there was at least one measurable lesion;
- The expected survival time was more than 12 weeks;
Exclusion
Exclusion Criteria:
- Patients who received any anti-tumor treatment within 4 weeks before enrollment,including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, orparticipated in another intervention clinical trial;
- Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
- The third space effusion (such as massive pleural effusion or ascites) with clinicalsymptoms that cannot be controlled by drainage or other methods;
- Allergy to any test drug and its excipients, or serious allergic history, orcontraindication of the test drug;
- Have a history of immunodeficiency, including HIV positive, or other acquired,congenital immunodeficiency diseases, or a history of organ transplantation;
Study Design
Total Participants: 50
Study Start date:
November 14, 2020
Estimated Completion Date:
August 30, 2022
Connect with a study center
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaActive - Recruiting

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