Node-sparing radiotherapy with chemotherapy and immunotherapy for rectal cancer

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 phase II clinical trial evaluates the effectiveness of node-sparing short-course radiotherapy combined with total neoadjuvant CAPOX chemotherapy and the PD-1 inhibitor Sintilimab in patients with microsatellite stable (MSS) locally advanced middle and low rectal cancer. The trial aims to enroll 47 patients and focuses on assessing the complete response rate, organ preservation, tumor regression, and overall survival rates. Participants will receive targeted radiation to the tumor bed while avoiding surrounding lymph nodes, followed by surgery. The study will also monitor adverse effects associated with the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
* Male or Female aged 18-75.
* Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum.
* Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
* Eastern Cooperative Oncology Group (ECOG) 0-1.
* No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).
* Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
* Informed consent form signed.

Exclusion Criteria:

* Patients with a previous history of malignant tumors besides rectal cancer.
* Patients with distant metastases before enrollment.
* Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
* Patients with obstruction, perforation, or bleeding that require emergency surgery.
* Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
* Allergic to any component of the therapy.
* Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.
* Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
* Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
* Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
* Patients with congenital or acquired immune deficiency (such as HIV infection).
* Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.

Other conditions that investigators consider not suitable for this study.

Where it's running

• Zhejiang University Affiliated Jinhua Hospital
  Jinhua, Zhejiang, China Recruiting

Study contacts

• Study coordinator: jinlin du, master
• Email: djl9090@163.com
• Phone: 86 13957998111

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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.