Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer

Fujian Provincial Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Mid-low Rectal Cancer

Treatments: Drug: Tislelizumab; Drug: Oxaliplatin; Radiation: Short-course Radiotherapy; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06333769

CATIMOR

Details and patient eligibility

About

To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer

Full description

In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

Experimental group

Description:

Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w \*2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.

Treatment:

Drug: Capecitabine

Radiation: Short-course Radiotherapy

Drug: Oxaliplatin

Drug: Tislelizumab