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

NCT06333769 | Completed Phase 2 DMC

• 1 other identifier: CATIMOR
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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

Conditions

Mid-low Rectal Cancer

Keywords

short-course radiotherapy; CAPOX; PD-1 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  Including pCR and CCR.

  From enrollment to 3 month and during follow-up

Secondary Outcomes (4)

• Organ preservation rate

  1 year.

• Quality of life

  Before each treatment, before surgery and during follow-up.

• 3y-DFS

  From enrollment to 36 month

• 3-year OS

  From enrollment to 36 month

Study Arms (1)

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

EXPERIMENTAL

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.

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

Interventions

Short-course Radiotherapy RADIATION

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

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

Tislelizumab DRUG

Tislelizumab：200mg，d1，q3w，2 cycles.

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

Capecitabine DRUG

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

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

Oxaliplatin DRUG

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

Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 immunotherapy.
• Ability to comply with the study protocol during the study period.
• Signed written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (3)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The Second Hospital of Longyan

Longyan, Fujian, 364000, China

Location

Jinjiang Municipal Hospital

Quanzhou, Fujian, 362200, China

Location

MeSH Terms

Interventions

tislelizumab; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: July 12, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 14, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (3)