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

Henan Cancer Hospital

Status and phase: Unknown; Phase 1

Conditions: Digestive System Tumors

Treatments: Drug: a CDK4 / 6 inhibitor and a MEK inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04615312

CRC-PANC-IIT-SHR6390-SHR7390

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-75 years;
2. ECOG score ≤ 1;
3. Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology 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 criteria

1. Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated 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 clinical symptoms that cannot be controlled by drainage or other methods;
4. Allergy to any test drug and its excipients, or serious allergic history, or contraindication 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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

a CDK4 / 6 inhibitor and a MEK inhibitor

Experimental group

Description:

Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment

Treatment:

Drug: a CDK4 / 6 inhibitor and a MEK inhibitor