Actively Recruiting
A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
Led by Fudan University · Updated on 2026-01-22
50
Participants Needed
2
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.
CONDITIONS
Official Title
A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosis of unresectable and metastatic colorectal cancer confirmed by histology or cytology
- Metastatic disease not limited to the liver (no liver metastasis or liver metastasis with other sites such as lung or peritoneum)
- Tumor tissue shows pMMR by immunohistochemistry or MSS/MSI-L by PCR or NGS
- Previous standard treatment including fluorouracil, oxaliplatin, irinotecan, with or without anti-VEGF antibody, and for RAS wild-type patients, anti-EGFR antibody; BRAF inhibitor recommended for BRAF mutation if available
- Disease progression or intolerance after standard treatment according to RECIST 1.1
- ECOG performance status 0-2 and expected survival of at least 3 months
- At least one measurable tumor lesion per RECIST 1.1
- Adequate organ function including neutrophils ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥9 g/dL, serum albumin ≥3 g/dL
- Normal thyroid function (TSH ≤1x upper limit, normal T3 and T4)
- Bilirubin ≤1.5x upper limit, ALT and AST ≤2x upper limit
- Serum creatinine ≤1.5x upper limit and creatinine clearance ≥60 mL/min
- INR or PT ≤1.5x upper limit unless on anticoagulants within therapeutic range
- aPTT ≤1.5x upper limit
- No serious concomitant diseases reducing survival under 5 years
- Negative pregnancy test for women of childbearing potential; infertile female patients
- Agreement to use contraception during study and for 12 months after treatment if of childbearing potential
- Signed informed consent
- Ability and willingness to comply with study schedule and procedures
- Not participating in other drug or medical device clinical trials during study
You will not qualify if you...
- Diagnosis of other intestinal tumors such as gastrointestinal stromal tumor
- Tumor tissue showing dMMR by immunohistochemistry or MSI-H by PCR or NGS
- Prior treatment with PD-1, PD-L1, or CTLA-4 antibodies
- History or current other malignancies except treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
- Active or history of autoimmune diseases including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid disorders (except stable autoimmune hypothyroidism), type I diabetes on stable insulin, vitiligo, or cured asthma/allergy without intervention
- History of immunodeficiency including HIV, acquired or congenital immunodeficiency, organ or bone marrow transplantation
- Contraindications to antiangiogenic drugs such as active bleeding or hemoptysis
- History of interstitial lung disease (excluding radiation pneumonitis without steroids) or non-infectious pneumonia
- Active pulmonary tuberculosis or history within 1 year without treatment
- Active hepatitis B or C infection as defined by viral load
- Severe heart, lung, or kidney dysfunction
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- History of substance abuse including alcohol or drugs
- Other conditions affecting safety or compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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