Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Recruiting Phase 2 Interventional Study
Microsatellite Stable Metastatic Colorectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
Fudan University · Other
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About This Trial
The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monother…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old 2. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1 3. Life expectancy of at least 3 months 4. Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum 5. At least one evaluable metastatic lesion for radiotherapy according…
Contacts

Zhen Zhang, MD, PHD

18801735029

zhen_zhang@fudan.edu.cn

CONTACT