Camrelizumab and Apatinib Combined With Chemotherapy (mFOLFOX6) in Neoadjuvant Therapy for Locally Advanced Colon Cancer

Zhejiang University1 site in 1 country64 target enrollmentJanuary 4, 2021

ConditionsColon Cancer Neoadjuvant Therapy

InterventionsCamrelizumab , apatinib and chemotherapy

DrugsCamrelizumab , apatinib and chemotherapy

Overview

Phase: Phase 2
Intervention: Camrelizumab , apatinib and chemotherapy
Conditions: Colon Cancer
Sponsor: Zhejiang University
Enrollment: 64
Locations: 1
Primary Endpoint: Tumor Regression Rate of MSS/pMMR Patients
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.

Detailed Description

To determine the rate of tumor regression grade 2-4 at time of radical resection of MSS/pMMR colon cancer following neoadjuvant treatment.To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment, pathologic complete response (pCR) rates, R0 resection rate, 2 year Disease free survival, OS(overall survival) and adverse events, including perioperative complication and mortality rate. To determine the pathologic downstage rates and pCR rate of radical resection of MSI/dMMR colon cancer.

Registry

clinicaltrials.gov

Start Date

January 4, 2021

End Date

September 30, 2023

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang University

Responsible Party

Principal Investigator

Weijia Fang, MD

Director of Medical Oncology

Zhejiang University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years, ≤75 years
•Histologically confirmed colon cancer ( tumor penetrated of muscularis propria depth ≥5mm of T3 , T4, N0-2, M0) without distant metastasis (AJCC 8th).
•Surgical treatment is planned after completion of neoadjuvant therapy
•Patients can swallow pills normally
•Expected overall survival ≥12 months
•Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts \> 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.
•AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine\<ULN
•Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
•Patients who have not received systemic chemotherapy or immunotherapy
•Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;

Exclusion Criteria

•Patients have received any prior systemic antitumor therapy;
•Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (\> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
•Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed.
•Certain or suspected distant metastases.
•The patient has a history of autoimmune disease.
•Serious uncontrolled systemic diseases, such as severe active infections;
•A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
•Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
•Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \>500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \< 500 IU/mL) may be enrolled
•Anti-infective therapy was not discontinued 14 days before the study;

Arms & Interventions

chemotherapy, PD-1 inhibitor and Apatinib

Participants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy.

Intervention: Camrelizumab , apatinib and chemotherapy