A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

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/A

Clinical Study ID

NCT04615312
CRC-PANC-IIT-SHR6390-SHR7390
  • Ages 18-75
  • All Genders

Study Summary

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-75 years;
  2. ECOG score ≤ 1;
  3. Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed byhistology or cytology and imaging diagnosis;
  4. According to Recist1.1, there was at least one measurable lesion;
  5. The expected survival time was more than 12 weeks;

Exclusion

Exclusion Criteria:

  1. 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;
  2. Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
  3. The third space effusion (such as massive pleural effusion or ascites) with clinicalsymptoms that cannot be controlled by drainage or other methods;
  4. Allergy to any test drug and its excipients, or serious allergic history, orcontraindication of the test drug;
  5. 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
    China

    Active - Recruiting

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