Combining PD-1 antibody with chemoradiotherapy for rectal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of combining a PD-1 monoclonal antibody with radical chemoradiotherapy in treating non-metastatic rectal squamous cell carcinoma (rSCC). Participants will receive a treatment regimen that includes chemotherapy with DDP and 5-FU, along with immunotherapy and radiotherapy. The study will assess survival outcomes and complete response rates compared to previous treatments. It is a multicenter, prospective, single-arm, phase II study designed to gather more data on this rare cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent;
2. 18-75 years old;
3. Patients with pathologically confirmed rectal squamous cell carcinoma;
4. imaging to rule out distant metastases;
5. Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment)

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

Exclusion Criteria:

1. Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma;
2. Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis);
3. 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);
4. 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);
5. 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;
6. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months;
7. New York Heart Association (NYHA) Class II or above congestive heart failure;
8. Prior receipt of any investigational drug;
9. Pregnant or lactating women;
10. Any medical condition that is unstable or would affect patient safety and their compliance with the study;
11. Patients judged by the investigator to be unsuitable to participate in this clinical trial.

Where it's running

• Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jun Huang, MD — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Jun Huang, MD
• Email: huangj97@mail.sysu.edu.cn
• Phone: +86-13926451242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.