Clinical trial · Observational
Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer
An Observational Real-world Study of Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Chinese Patients With Advanced Colorectal Cancer
- 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 is a multicenter observational study aimed to describe the efficacy and safety of regorafenib plus programmed cell death-1 (PD-1) inhibitors in Chinese patients with advanced colorectal cancer in routine clinical practice. The primary end point is overall survival. The secondary endpoints include progression-free survival, objective response rate, disease control rate and the incidence of treatment-related adverse events.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Regorafenib | Drug | Regorafenib | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 24 months
- description
- The time from treatment initiation to death due to any cause
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- Up to 24 months
- description
- The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 12 months
- description
- The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using RECIST 1.1 criteria at any time during the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age and older 2. Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma 3. Disease progression on standard of care therapy 4. Patients must have received at least one dose of PD-1 inhibitors in combination with regorafenib 5. At least one available laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment for safety analysis 6. Confirmed treatment discontinuation/disease progression/available radiological evaluation or at least eight weeks of follow-up subsequent to the first dose of study treatment for efficacy analysis 7. Prior exposure to regorafenib monotherapy or a PD-1 inhibitor monotherapy was allowed Exclusion Criteria: 1. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin 2. Participation in other interventional studies while receiving regorafenib plus a PD-1 inhibitor
References
Publications (1)
- DERIVEDYang K, Han L, Wu S, Qu X, Li Q, Zhao C, Zhou J, Jin X, Wang Y, Yan D, Cheng Z, Hua Y, Zhang Y, Ge Y, Sun J, Deng W, Zhao L, Zhao Y. Real-world outcomes of regorafenib combined with immune checkpoint inhibitors in patients with advanced or metastatic microsatellite stable colorectal cancer: A multicenter study. Cancer Immunol Immunother. 2022 Jun;71(6):1443-1451. doi: 10.1007/s00262-021-03083-3. Epub 2021 Oct 24. PMID 34689233