Actively Recruiting
Randomized Study Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Plus Cadonilimab and Second-Line Therapy Versus Second-Line Therapy Alone in Colorectal Cancer With Peritoneal Metastasis
Led by Fudan University · Updated on 2025-12-24
40
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two treatment approaches for patients with colorectal cancer that has spread to the peritoneum. It focuses on evaluating the objective response rate of 68Ga-FAPI PET-guided abdominal radiotherapy combined with second-line standard therapy and cadonilimab versus cabozantinib combined with second-line standard therapy. The study also examines disease control, duration of remission, progression-free survival, overall survival, and safety of these treatments. Participants in this Phase 2 trial are randomly assigned to one of two groups. The experimental group receives radiotherapy targeting abdominal lesions with a dose of 20-25 Gy over five daily sessions, followed one week later by immunotherapy with cadonilimab administered every two weeks, along with standard second-line chemotherapy regimens such as XELOX/FOLFOX or XELIRI/FOLFIRI, potentially combined with bevacizumab or cetuximab. The control group receives only the standard second-line chemotherapy. Treatments are given according to a fixed schedule during the study. Throughout the trial, participants will be regularly assessed from enrollment through two treatment cycles (each lasting 14 days) to measure response rates and track disease progression and survival. Laboratory tests will monitor organ function and safety. Participants will be followed until disease progression or study completion, with informed consent and adherence to visit schedules required. The study is sponsored by Fudan University and began in March 2024, with a planned end in May 2028.
CONDITIONS
Brief 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
- Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination
- Disease progression after standard first-line treatment, excluding prior immunotherapy
- Eastern Cooperative Oncology Group (ECOG) score of 0-1
- Expected survival time of at least 24 weeks
- Laboratory tests within 7 days before first treatment within study requirements
- Women of childbearing potential must have a negative pregnancy test within 7 days before first treatment
- Use of effective contraception during the study and for 6 months after last study medication
- Voluntary informed consent and willingness to follow study plan and visits
You will not qualify if you...
- Absolute neutrophil count less than 1.5 x 10^9/L or platelet count less than 100 x 10^9/L (or less than 80 x 10^9/L if liver metastasis present), or hemoglobin below 9 g/dL
- Blood transfusion within 2 weeks prior to enrollment
- Serum bilirubin above 1.5 times upper limit of normal (2.5 times if liver metastasis)
- AST or ALT above 2.5 times upper limit (5 times if liver metastasis)
- Serum creatinine above 1.5 times upper limit or creatinine clearance below 50 ml/min
- Prolonged clotting times (APTT or PT greater than 1.5 times normal)
- Severe electrolyte abnormalities
- Significant proteinuria (urine protein 2+ or above, or 24-hour urine protein ≥1.0 g/24h)
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Active digestive tract diseases causing bleeding or risk of perforation
- 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 major heart disease or heart dysfunction (NYHA class 2 or above, LVEF <50%)
- Uncontrolled malignant effusions
- Previous treatment with certain immune checkpoint inhibitors
- Radiotherapy within 4 weeks before enrollment
- Active second primary malignancy or recent other cancers except specific types
- Known liver disease including hepatitis B or C infection or cirrhosis
- Pregnant or breastfeeding women or positive pregnancy test
- Any clinical or lab abnormalities making participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks for radiotherapy plus continuing chemotherapy every two weeks thereafter
Participants receive either radiotherapy followed by immunotherapy and chemotherapy or standard second-line chemotherapy alone.
5 daily visits for radiotherapy followed by visits every two weeks for immunotherapy and chemotherapy
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
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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