Node-sparing radiation with CAPOX and Tislelizumab for rectal cancer

Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)

This study is testing a new way to treat middle and low rectal cancer using a special type of radiation along with chemotherapy and an immune therapy to see if it works better than the usual treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Tislelizumab
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT06507371 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of node-sparing modified short-course radiation combined with CAPOX and the PD-1 inhibitor Tislelizumab in patients with middle and low rectal cancer. It is a randomized, multicenter, open-label Phase III trial involving 170 patients, comparing this novel approach to standard short-course radiation combined with CAPOX. The primary goal is to assess the rate of pathological complete response (pCR), while also analyzing event-free survival (EFS), overall response rate (ORR), organ preservation rate, long-term prognosis, and adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with low rectal cancer who are willing to undergo neoadjuvant therapy and have specific tumor characteristics.

Not a fit: Patients with prior treatments for rectal cancer or those with advanced metastatic disease may not benefit from this study.

Why it matters

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

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for rectal cancer patients.

Eligibility criteria

Inclusion Criteria:

1. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
2. Male or Female aged 18-75.
3. 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 cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) score 0-1.
6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
7. Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy.
8. Informed consent form signed.

Exclusion Criteria:

1. Patients with a previous history of malignant tumors besides rectal cancer.
2. Patients with distant metastases before enrollment.
3. Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
4. Patients with obstruction, perforation, or bleeding that require emergency surgery.
5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
6. Allergic to any component of the therapy.
7. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
8. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
9. 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.
10. Patients with congenital or acquired immune deficiency (such as HIV infection).
11. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
12. Other conditions that investigators consider not suitable for this study.

Where this trial is running

Hanzhou, Zhejiang

• Sir Run Run Shao hospital — Hanzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhangfa Song, M.D, PH.D

Conditions Rectal Cancer; node-sparing radiation; PD-1; MSS; short-course radioation