RecruitingPhase 2NCT06841159

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1,Chemotherapy and Target Therapy for Metastatic Colorectal Cancer

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


Sponsor

Fudan University

Enrollment

116 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ultra-precise, adaptive radiation therapy (called PULSAR — Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) can help "wake up" the immune system to attack colorectal cancer that has spread. The idea is that high-dose, precisely targeted radiation may cause a systemic immune response. **You may be eligible if...** - You are between 18 and 75 years old - You have colon or rectal cancer that has spread (metastatic), with 10 or fewer metastatic sites, all safely treatable - Your cancer is confirmed as MSS/pMMR type (a specific genetic subtype) - Your general health (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have MSI-H or dMMR cancer (a different genetic subtype) - You have had radiation therapy within the past 6 months - Your cancer has spread too widely to treat all sites - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONUltra-fractionated radiation therapy

Radiation therapy will be delivered every 3 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of sintilimab.

DRUGSintilimab

Sintilimab will be given at 200 mg q3w every 3 weeks and schedule to the next day of every pulses of radiation.

DRUGStandard systemic therapy

First-line standard systemic therapies in cohort A include: FOLFOX/FOLIRI/XELOX+ bevacizumab, FOLFOX/FOLIRI/XELOX+cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only). Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT), FOLFIRI/irinotecan+raltitrexed/irinotecan/+bevacizumab, FOLFIRI/irinotecan+raltitrexed/irinotecan/+cetuximab (KRAS/NRAS/BRAF WT), based on the previous first-line chemotherapy and adverse events.


Locations(1)

Fudan University

Shanghai, China

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NCT06841159


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