Combining PD-1 antibody with chemoradiotherapy for rectal squamous cell carcinoma
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma: A Multicenter, Prospective, Single Arm, Phase II Study(RICH).
This study is testing if adding a PD-1 antibody to standard chemotherapy and radiation can help people with non-metastatic rectal squamous cell carcinoma live longer and have better treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, sintlimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06364384 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed non-metastatic rectal squamous cell carcinoma.
Not a fit: Patients with a history of other malignant tumors or those who have previously received treatment for rectal squamous cell carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with rectal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.