Clinical trial · Observational
Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer
Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting
NCT06011330CI-TRIAL-00069176completedClinicalTrials.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)
The survival of the refractory CRC is dismal and therapy options are limited ,the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib combined with anti-PD-1 antibodies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- study group
- description
- fruquintinib combined with anti-PD-1 antibodies
- interventionNames
- Drug: Fruquintinib combined with anti-PD-1 antibodies
Primary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- assessed up to 2 year
- description
- Overall survival defined as the observed time from the treatment of the study until death due to any cause
Secondary outcomes (1)
- measure
- progress-free survival (PFS)
- timeFrame
- assessed up to 1 year
- description
- the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022; 2. Eligible patients were aged 18 years or older 3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; 4. patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1). 5. an Eastern Cooperative Oncology Group performance status of 0-2; Exclusion Criteria: 1. Pregnancy, lactating female or possibility of becoming pregnant during the study. 2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation). 3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 4. Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
References
Publications (0)
Data not yet available
No reference posted for this study.