Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04110093

Enrollment

120

Registered

2019-10-01

Start date

2019-03-01

Completion date

2021-08-31

Last updated

2020-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Immunotherapy

Keywords

Colorectal Cancer, Immunotherapy, Regorafenib, Nivoluamb, microsatellite stable

Brief 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).

Interventions

DRUGRegorafenib 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Progress Free Survival	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months	Time from treatment beginning until disease progression

Secondary

Measure	Time frame	Description
Overall Survival	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months	Time from treatment beginning until death from any cause
Adverse Effect	Through study completion, an average of 1 months	Incidence of Treatment-related adverse Events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026