Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
Recruiting
Phase 2
Phase 3
Interventional Study
Colorectal Cancer
Liver Metastases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 156 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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About This Trial
The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 and ≤75 years old
* Histologically confirmed colorectal adenocarcinoma
* Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions
* Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
* Absence of extr…
Contacts