Sponsor study identifier
interventional
20
1 country
1
Study Start
April 12, 2024
Actual (reported)Primary Completion
September 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 8, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2024
Actual (reported)April 12, 2024
Actual (reported)April 15, 2024
Actual (reported)September 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 8, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
3-year tumor-free survival(DFS)
The proportion of patients who do not have any of the following events from the beginning of randomization to the end of the first year
3 year
1-year overall survival (OS)
1 year
1-year relapse-free survival (RFS)
1 year
1-year metastasis free survival (DMFS)
1 year
Incidence of chemotherapy and immunotherapy-related adverse reactions
through study completion, an average of 6 months
Complete response rate (CRR)
through study completion, an average of 6 months
Patients from experimental group are underwent treatment together with PD-1 monoclonal antibody and radical CRT
Chemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Jun Huang, MD
Sixth Affiliated Hospital, Sun Yat-sen University
First Submitted
April 2, 2024
First Posted
April 15, 2024
Study Start
April 12, 2024
Actual (reported)Primary Completion
September 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
June 8, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 1, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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