Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma

NCT06364384 | Recruiting Phase 2 DMC

• 1 other identifier: E2024074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Squamous Cell Carcinoma

Keywords

PD-1; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (1)

PD-1 + CRT

EXPERIMENTAL

Patients from experimental group are underwent treatment together with PD-1 monoclonal antibody and radical CRT

Combination Product: PD-1 and CRT

Interventions

PD-1 and CRT COMBINATION_PRODUCT

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).

PD-1 + CRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent;
• 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)
• White blood cell (WBC) ≥ 3.0×109/L or neutrophil (ANC) ≥1.5×109/L;
• Hemoglobin (HGB) ≥80 g/L;
• Platelets (PLT) ≥ 100×109/L;
• Hepatic transaminases (AST/ALT) \< 3.0 times the upper limit of the normal range;
• Total bilirubin (TBIL) \< 1.5 times the upper limit of the normal range;
• Creatinine (CREAT) \< 1.5 times the upper limit of the normal range.
• ECOG performance status score of 0-2;
• No history of other malignant tumors in the past.

You may not qualify if:

• Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma;
• Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis);
• Previous or concurrent presence of other active malignancies (except for malignant tumors that have received curative therapy and have been disease-free for more than 3 years or carcinoma in situ that can be cured by adequate treatment);
• Major surgery such as laparotomy, thoracotomy, resection of organs by laparoscopic surgery or severe trauma within the past 4 weeks (the surgical incision should be completely healed before randomization);
• Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to enrollment in the study;
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months;
• New York Heart Association (NYHA) Class II or above congestive heart failure;
• Prior receipt of any investigational drug;
• Pregnant or lactating women;
• Any medical condition that is unstable or would affect patient safety and their compliance with the study;
• Patients judged by the investigator to be unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Study Officials

• Jun Huang, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Huang, MD

CONTACT

+86-13926451242; huangj97@mail.sysu.edu.cn

Fang He, MD

CONTACT

+86-18826059789; hefang23@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: April 12, 2024
• Primary Completion: April 20, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-04

Locations

CN (1)