Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110093
• Other study ID #: CZ-REGONIVO
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2020
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Advanced Colorectal Cancer diagnosed histologically;

• Patients with microsatellite stable (MSS)

• Patients have no any standard choice after multiple line of therapy( = 2 lines);

• Expected survival = 3 month;

• ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB = 90g / L, ANC = 1.5 × 109 / L, PLT = 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr = 1 × ULN, endogenous creatinine clearance =50ml/min

Exclusion Criteria:

• Patient still has standard treatment therapy based on NCCN guidance;

• Patient can not comply with research program requirements or follow-up;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Immunotherapy

Intervention

Drug:
• Regorafenib and PD-1 inhibitor
All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).

Locations

Country	Name	City	State
China	Department of Medical Oncology, Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Primary	Progress Free Survival	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Secondary	Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Secondary	Adverse Effect	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months