Actively Recruiting
Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-08-24
57
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.
CONDITIONS
Official Title
Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced colorectal adenocarcinoma confirmed to have MSS/pMMR by histology or cytology
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to take oral medications
- Expected survival of at least 3 months
- Disease progression after standard second-line or later therapy including oxaliplatin, irinotecan, and fluorouracil analogs
- Presence of measurable target lesions according to RECIST v1.1
- No more than 2 recurrent metastatic organs for all measurable lesions
- Maximum diameter of recurrent metastatic lesions 5 cm or less
- Total number of recurrent metastatic lesions 10 or fewer
- Agreement to provide stored tumor tissue or undergo biopsy for biomarker analysis
- Recent chest, abdomen, and pelvis CT or whole body PET-CT within 4 weeks before enrollment
- No ascites
- Adequate major organ function and normal ECG, blood, and biochemistry tests to allow chemotherapy and radiotherapy
- Hemoglobin greater than 8 g/L, platelets 100 x 10^9/L or higher, neutrophils 1.5 x 10^9/L or higher
- For patients with liver metastases, aminotransferase and bilirubin levels less than 5 times upper normal limit
- For patients without liver metastases, aminotransferase and bilirubin less than 2.5 times upper normal limit
- Women of childbearing potential must have a negative pregnancy test and use contraception
- Prior systemic therapy and radiation therapy for other lesions allowed
- If symptoms from tumor require, radiotherapy may be discussed and given
- Ability to remain in fixed position during radiotherapy if required
- Ability to tolerate immobilization devices if stereotactic ablative radiotherapy (SABR) is needed
- Good control of primary tumor site with no progression for at least 3 months after radical treatment or judged stable by investigator
You will not qualify if you...
- Prior treatment with trifluridine tepidopyrimidine
- Prior treatment with PD-1 or PD-L1 monoclonal antibodies
- Extensive bone metastases
- Extensive peritoneal metastases
- Malignant pleural effusion or ascites
- Spinal cord compression or dural sac tumors close to spinal cord unless surgically resected (max 3 sites)
- Unstable brain metastases requiring surgery
- Brainstem metastases
- Metastases invading gastrointestinal tract or skin where radiation dose cannot be adequately given
- Multiple intracranial metastases only
- Pregnant or breastfeeding women
- Lack of reliable contraception during reproductive period
- Known allergy to study drugs or their components
- Risk of gastrointestinal bleeding or obstruction
- History of thromboembolism except from PICCs or infusion ports
- Uncontrolled high blood pressure after treatment
- Other chronic diseases contraindicating treatment
- Active infections
- Pre-existing severe immunotherapy-related conditions (myocarditis, pneumonia, colitis, hepatitis, nephritis)
- Existing severe side effects (grade 2 or higher) from prior therapy except alopecia or hyperpigmentation
- Severe medical conditions preventing radiotherapy including certain lung, gastrointestinal, or connective tissue diseases
- Overlapping radiation fields with prior radiotherapy exceeding dose limits
- Prior systemic radionuclide therapy such as Radium-223 or Lutetium-177
- Other investigator-determined factors making participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
W
Weiwei Xiao, M.D.
CONTACT
L
Liping Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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