Radiation Plus Immunotherapy and Standard Drugs for Colorectal Cancer That Has Spread

Trial details

Who runs it

Fudan University

Trial code

NCT06841159

Record updated

19 October 2026

Original description

To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.Read full original descriptionShow less

Phase 2 Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1, Chemotherapy and Target Therapy for Metastatic Colorectal Cancer(iPULSAR-CRC)

To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.

Inclusion: Patient is 18-75 years old at the time of signing the informed consent form; ECOG performance status 0-1; Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum; Distant metastasis lesions are no more than 10 and all sites of disease can be safely treated based on a pre-plan; At least one evaluable metastatic lesion for radiotherapy and evaluation according to RECIST 1.1; No prior radiotherapy within 6 month; Previous system therapy. Patients Group Cohort A: participants who have not previously been treated with first-line chemotherapy. Cohort B: Patients with disease progression after first-line chemotherapy or stopped first-line therapy due to unacceptable toxic effects ; Has an investigator determined life expectancy of at least 24 weeks; Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors; Non pregnant or lactating patients. Effective contraceptive methods should be used during the study and within 6 months of the last administration; Fully informed and willing to provide written informed consent for the trial.

Exclusion: Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication, or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period; History of checkpoint inhibitor therapy; Uncontrolled hypertension: SBP >140 mmHg or DBP > 90 mmHg; A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months; A history of heart disease within 6 months; Uncontrolled malignant pleural effusion, ascites, or pericardial effusion; The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years; Neutrophil< 1.5×109/L, PLT< 100×109/L (PLT< 80×109/L in patients with liver metastasis), or Hb< 90 g/L; TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and/or AST > 5 ULN in patients with liver metastasis; Cr > 1.5 ULN, or creatinine clearance< 50 mL/min (calculated according to Cockcroft Gault formula); APTT > 1.5 ULN, PT > 1.5 ULN (subject to the normal value of the clinical trial research center); A history of liver disease including, but not limited to, HBV infection or HBV DNA positive (≥1×104/mL), HCV infection or HCV DNA positive (≥1×103/mL),and liver cirrhosis; The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems; Serious electrolyte abnormalities; Urinary protein ≥ 2+, or 24-h urine protein ≥1.0 g/24 h; Serious mental abnormalities; The diameter of brain metastasis is greater than 3 cm or the total volume is greater than 30 cc; Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI.

ClinicalTrials.gov NCT06841159