Clinical trial · Interventional
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
NCT04110093CI-TRIAL-00049180unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib and PD-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotherapy Combination treatment
- description
- All colorectal cancer patients received regorafenib plus PD-1 inhibitor
- interventionNames
- Drug: Regorafenib and PD-1 inhibitor
Primary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
- description
- Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
- measure
- Progress Free Survival
- timeFrame
- Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.