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

NCT ID: NCT06333769

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2025-08-14

Brief Summary

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

Detailed 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.

Conditions

Mid-low Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

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.

Group Type: EXPERIMENTAL

Short-course Radiotherapy

Intervention Type: RADIATION

Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

Tislelizumab

Intervention Type: DRUG

Tislelizumab：200mg，d1，q3w，2 cycles.

Capecitabine

Intervention Type: DRUG

Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin：130mg/m2, d1, q3w, 2 cycles

Interventions

Short-course Radiotherapy

Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

Intervention Type: RADIATION

Tislelizumab

Tislelizumab：200mg，d1，q3w，2 cycles.

Intervention Type: DRUG

Capecitabine

Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin：130mg/m2, d1, q3w, 2 cycles

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Hospital of Longyan

Longyan, Fujian, China

Jinjiang Municipal Hospital

Quanzhou, Fujian, China

Countries

China

Other Identifiers

CATIMOR

Identifier Type: -

Identifier Source: org_study_id