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The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime? Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.
Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
Full description
Rectal squamous cell cancer (rSCC) is a rare malignancy, and its incidence is increasing year by year. Due to the rarity of rSCC, there is no consensus on its epidemiology, pathogenesis, prognosis and treatment management. Due to the limitation of clinical data, there is an urgent need for further clinical exploration and research.
In recent years, the combination of CRT and immunotherapy has attracted more and more attention, as they may have more advantages over CRT alone.A number of prospective clinical trials of PD-1 monoclonal antibody combined with CRT for the first-line treatment of advanced aSCC are also underway (NCT03233711, NCT04230759, NCT05661188, NCT05374252, etc.). Similarly, the efficacy and safety of PD-1 monoclonal antibody in rSCC patients are also worthy of further discussion, in order to further improve the survival prognosis of rSCC patients. Our previous study data showed that the 3-year OS and DFS of radical CRT were 88.9% and 66.7%, respectively, for non-metastatic rSCC, and 100% and DFS for radical CRT combined with immunotherapy, respectively, and CRT combined with immunotherapy significantly improved survival compared with radical CRT (P=0.02).
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. Therefore, we plan to conduct a multicenter, prospective, single-arm, phase II study to provide evidence-based medical evidence for the treatment of locally advanced rectal squamous cell carcinoma.
The primary outcome is 1-year tumor-free survival (DFS), and the secondary outcomes are including 1-year overall survival (OS), 1-year relapse-free survival (RFS), 1-year metastasis free survival (DMFS), 1-year stoma-free survival, incidence of chemotherapy and immunotherapy-related adverse reactions and complete response rate (CRR).
Participants will receive interventions below:
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Inclusion criteria
Voluntarily sign the informed consent;
18-75 years old;
Patients with pathologically confirmed rectal squamous cell carcinoma;
imaging to rule out distant metastases;
Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment)
ECOG performance status score of 0-2;
No history of other malignant tumors in the past.
Exclusion criteria
Primary purpose
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20 participants in 1 patient group
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Central trial contact
Fang He, MD; Jun Huang, MD
Data sourced from clinicaltrials.gov
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