NCT06841159 Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Cancer
| NCT ID | NCT06841159 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Microsatellite Stable Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 116 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * History of checkpoint inhibitor therapy. * 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). * Serious electrolyte abnormalities. * Urinary protein ≥ 2+, or 24-h urine protein ≥1.0 g/24 h. * 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. * 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. * 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. * 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06841159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Microsatellite Stable Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06841159 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06841159 currently recruiting?
Yes, NCT06841159 is actively recruiting participants. Contact the research team at zhen_zhang@fudan.edu.cn for enrollment information.
Where is the NCT06841159 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06841159 clinical trial?
NCT06841159 is sponsored by Fudan University. The trial plans to enroll 116 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.