NCT05576480 SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
| NCT ID | NCT05576480 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2025-10 |
Trial Parameters
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Brief Summary
The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.
Eligibility Criteria
Inclusion Criteria: * Informed consent * 18 years \< age ≤ 75 years * ECOG score is 0-1 * Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual * Without emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer * Microsatellite Instability detection using PCR capillary electrophoresis results in MSS * Without any anti-tumor treatment * No distant metastasis * Have an imaging measurable or clinically assessable lesion * Adequate organ and bone marrow function * Female participants of childbearing age or male participants whose sexual partners are women of childbearing age are required to use effective contraception for the entire treatment period and for 6 months after the end of the treatment period Exclusion Criter
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