Actively Recruiting
Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis
Led by Fudan University · Updated on 2025-12-24
40
Participants Needed
2
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Main objective: 1\. To compare the objective response rate (ORR) of 68Ga-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. Secondary objectives: 1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS), and overall survival (OS) of 68Ga-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. 2. To evaluate the safety and tolerability of 68Ga-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.
CONDITIONS
Official Title
Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed peritoneal metastasis of colorectal cancer by histological or cytological examination
- Disease progression after standard first-line treatment excluding any immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 24 weeks
- Laboratory tests for bone marrow, liver, kidney function, and coagulation meeting study requirements within 7 days before first treatment
- Negative blood pregnancy test within 7 days before first treatment for women of reproductive potential
- Use of effective contraception during the study and for 6 months after treatment for patients with reproductive capability
- Voluntary consent to participate and follow study treatment and visit schedule
You will not qualify if you...
- Absolute neutrophil count less than 1.5 × 10⁹/L, platelet count less than 100 × 10⁹/L (or less than 80 × 10⁹/L if liver metastasis), or hemoglobin less than 9 g/dL
- Blood transfusion within 2 weeks prior to enrollment
- Serum total bilirubin exceeding 1.5 times upper normal limit (2.5 times if liver metastasis)
- AST or ALT levels greater than 2.5 times upper normal limit (5 times if liver metastasis)
- Serum creatinine more than 1.5 times upper normal limit or creatinine clearance below 50 ml/min
- Partial thromboplastin time or prothrombin time exceeding 1.5 times upper normal limit
- Severe electrolyte abnormalities deemed significant by the researcher
- Urine protein 2+ or higher, or 24-hour urine protein ≥ 1.0 g/24h
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Active peptic ulcer, ulcerative colitis, digestive diseases with bleeding risk, or unrecovered gastrointestinal perforation or fistula
- History of arterial or deep vein thrombosis within 6 months, or bleeding tendency within 2 months
- Stroke or transient ischemic attack within 12 months
- Recent serious heart disease or heart dysfunction (NYHA class 2 or above), or left ventricular ejection fraction below 50%
- Uncontrolled malignant pleural effusion, ascites, or pericardial effusion
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or similar agents
- Radiotherapy within 4 weeks before enrollment
- Clinically detectable second primary cancer or other malignancies within past 5 years except certain skin, cervical, or bladder tumors
- Known significant liver disease including hepatitis B or C infection, or liver cirrhosis
- Pregnancy or lactation, or unwillingness to use strict contraception during the study
- Any other clinical or laboratory conditions making participation unsuitable as judged by the researcher
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, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Completed
Research Team
G
Guoxiang Cai
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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