Node-sparing radiotherapy with chemotherapy and immunotherapy for rectal cancer

Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial

This study is testing a new way to treat locally advanced rectal cancer using targeted radiation, chemotherapy, and immunotherapy to see if it helps patients keep their organs and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinhua Central Hospital (other)
• Drugs / interventions: immunotherapy, radiation, Sintilimab
• Locations: 1 site (Jinhua, Zhejiang)
• Trial ID: NCT06204094 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with locally advanced low rectal cancer who are willing to undergo neoadjuvant therapy and have not received prior treatments.

Not a fit: Patients with previous anti-tumor therapies, pelvic radiation, or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance organ preservation and improve treatment outcomes for patients with rectal cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination is novel and under evaluation.

Eligibility criteria

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 this trial is running

Jinhua, Zhejiang

• Zhejiang University Affiliated Jinhua Hospital — Jinhua, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: jinlin du, master

Conditions: Locally Advanced Rectal Cancer, rectal cancer, microsatellite stability, node-sparing, CAPOX, radiotherapy, sintilimab, immunotherapy