Combining short-course radiotherapy with chemotherapy and immunotherapy for rectal cancer

A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer

This study is testing a new treatment for locally advanced mid-low rectal cancer that combines short radiation therapy with a specific chemotherapy and immunotherapy to see if it helps shrink tumors better and safely preserve the organ.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, tislelizumab, radiation
• Locations: 3 sites (Fuzhou, Fujian and 2 other locations)
• Trial ID: NCT06333769 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a modified short-course radiotherapy regimen followed by the combination of tislelizumab, a PD-1 monoclonal antibody, and CAPOX chemotherapy in patients with locally advanced mid-low rectal cancer. The approach seeks to enhance tumor regression and increase the complete response rate by leveraging the synergistic effects of radiation and immunotherapy. Eligible participants will receive this treatment as a neoadjuvant therapy, potentially allowing for organ preservation and a 'wait-and-see' strategy. The study will assess the complete response rate and overall safety of this innovative treatment combination.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed mid-low rectal adenocarcinoma and specific staging criteria.

Not a fit: Patients with distant metastasis, prior anti-tumor treatments, or certain pathological diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the complete response rates in patients with locally advanced rectal cancer, offering a new option for organ preservation.

How similar studies have performed: Other studies have shown promising results with similar combinations of radiotherapy and immunotherapy, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age 18-75 years, any gender.
* Pathologically confirmed rectal adenocarcinoma.
* Baseline MR stage T3-4/N+.
* Distance from anal verge ≤12cm.
* No distant metastasis.
* Karnofsky Performance Status ≥70.
* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
* Microsatellite/mismatch repair status MSS/pMMR.
* No prior chemotherapy or any other anti-tumor treatment before inclusion.
* No prior immunotherapy.
* Ability to comply with the study protocol during the study period.
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or lactating women.
* Pathological diagnosis of signet ring cell carcinoma.
* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
* Patients with autoimmune diseases.
* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
* Known deficiency of dihydropyrimidine dehydrogenase (DPD).
* Allergy to any investigational drug components.

Where this trial is running

Fuzhou, Fujian and 2 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• The Second Hospital of Longyan — Longyan, Fujian, China (Not_yet_recruiting)
• Jinjiang Municipal Hospital — Quanzhou, Fujian, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Chunkang Yang, Doctor

Conditions Mid-low Rectal Cancer; short-course radiotherapy; CAPOX; PD-1 monoclonal antibody