Actively Recruiting
ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-08-09
68
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.
CONDITIONS
Official Title
ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- ECOG performance status of 0 or 1
- Histologically confirmed advanced or recurrent colorectal adenocarcinoma
- Confirmed normal mismatch repair protein expression (pMMR) or microsatellite stable (MSS) status
- Peripheral blood ctDNA maxVAF less than 6.5% as detected by next-generation sequencing
- Metastatic colorectal cancer that failed prior treatment with fluoropyrimidine, oxaliplatin, irinotecan plus bevacizumab or cetuximab (for left-side RAS/BRAF wild-type)
- At least 28 days since last systemic therapy (oral fluoropyrimidine ≥14 days), with palliative radiation allowed if completed more than 3 weeks prior
- At least one measurable lesion per RECIST v1.1 criteria
- Expected survival of at least 3 months
- Adequate organ and bone marrow function within 7 days before enrollment, including specified blood counts, liver and kidney function, coagulation parameters
- Normal electrocardiogram and left ventricular ejection fraction ≥50%
- No history of other malignancies except certain cured or non-invasive cancers with disease-free survival ≥5 years
- Negative pregnancy test for women of childbearing potential and willingness to use effective contraception
- Voluntary informed consent to participate in the trial
You will not qualify if you...
- Prior treatment with fruquintinib or similar anti-angiogenic small molecule oral targeted drugs
- Prior treatment with PD-1, PD-L1, CTLA-4 antibody therapies or other immunotherapies targeting these checkpoints
- History of severe hypersensitivity to monoclonal antibodies
- Active autoimmune diseases or history of autoimmune diseases requiring immunosuppressive treatment, except certain controlled conditions like vitiligo or well-controlled type I diabetes
- Use of immunosuppressive agents or corticosteroids exceeding 10mg prednisone equivalent within 2 weeks before dosing
- Conditions affecting oral drug intake such as dysphagia, post-gastrointestinal surgery complications, chronic diarrhea, or intestinal obstruction
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- History or signs of bleeding disorders, recent severe bleeding events, unhealed wounds, fractures, or active gastrointestinal bleeding conditions
- Known brain metastases or history of organ transplantation
- Receipt of approved or investigational anti-tumor treatments within 4 weeks before study start
- Vaccination with preventive or attenuated vaccines within 4 weeks before first dose
- Severe or uncontrolled diseases including uncontrolled blood pressure, recent thrombotic or cardiac events, active infections, significant liver disease, HIV positive status, or poorly controlled diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
A
Aiping Zhou, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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