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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mid-low Rectal Cancer
• Intervention / Treatment: Radiation: Short-course Radiotherapy; Drug: Tislelizumab; Drug: capecitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kang chun kang, Doctor; Phone Number: 86 13509333116; Email: chuck330@163.com
• Study Contact Backup: Name: Li jin luan, Doctor of Medicine; Phone Number: 86 15159628678; Email: lijinluan@pku.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short-course Radiotherapy Combined with CAPOX and Tislelizumab	Radiation: Short-course Radiotherapy; Rectal lesions + metastatic lymph nodes, DT: GTV-P 30Gy/5Fx. Pelvic lymphatic drainage area, DT: CTV-P 22.5Gy/5Fx.; Drug: Tislelizumab; Tislelizumab：200mg，d1，q3w，2 cycles.; Drug: capecitabine; capecitabine：1000mg/m2， d1-14，2 cycles.; Drug: Oxaliplatin; oxaliplatin：130mg/m2 d1，q3w, 2 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complete response (CR) rate	From enrollment to 3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
3y-DFS	From enrollment to 36 month

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Capecitabine; Oxaliplatin; Tislelizumab
• Other Study ID Numbers: CATIMOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No