Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

Fujian Provincial Cancer Hospital

Status and phase: Begins enrollment in 4 months; Phase 2

Conditions: Locally Advanced Rectal Cancer

Treatments: Radiation: Modified Short-course radiotherapy; Radiation: Long-course radiotherapy; Drug: Capecitabine; Drug: Tislelizumab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07469306

CATIMOR-2

Details and patient eligibility

About

To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Full description

In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.

Enrollment: 130 estimated 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab

Experimental group

Description:

Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w \*4 cycles.Efficacy and surgery were assessed after the end of treatment.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Tislelizumab

Drug: Tislelizumab

Drug: Capecitabine

Radiation: Modified Short-course radiotherapy

Long-course radiotherapy Combined with Capecitabine and Tislelizumab

Active Comparator group

Description:

Long-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.

Treatment:

Drug: Capecitabine

Drug: Tislelizumab

Drug: Tislelizumab

Drug: Capecitabine

Radiation: Long-course radiotherapy