MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

NCT ID: NCT06840665

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2027-02-12

Brief Summary

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Conditions

Locally Advanced Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

The patients will receive conventional pelvic radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: DRUG

PD-1 antibody (Toripalimab): 240mg d1 q3w

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 bid d1-14 q3w

Group B

The patients will receive lymph node-sparing radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: DRUG

PD-1 antibody (Toripalimab): 240mg d1 q3w

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 bid d1-14 q3w

Interventions

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg d1 q3w

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

Intervention Type: DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid d1-14 q3w

Intervention Type: DRUG

Other Intervention Names

Toripalimab

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 years old, male or female

2. Pathologically confirmed rectal adenocarcinoma

3. The distance from anal verge ≤ 10 cm

4. Clinical stage T3-4 and/or N+

5. No evidence of distance metastases

6. MSI/MMR status: MSS/pMMR

7. Karnofsky score >=70

8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy

9. No chemotherapy or any other anti-tumor therapy prior to enrollment

10. No immunotherapy prior to enrollment

11. With good compliance during the study

12. Signed written informed consent

Exclusion Criteria

1. Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ

2. Pregnancy or breast-feeding women

3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications

4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months

5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy

6. Individuals with autoimmune diseases

7. Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases

8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L

9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency

10. Individuals allergic to any drug component of the study

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

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Zhang, MD

Role: CONTACT

zhen_zhang@fudan.edu.cn

+86 18017312217

Facility Contacts

Zhang Zhen, MD PhD

Role: primary

zhen_zhang@fudan.edu.cn

+86 18017312217

Other Identifiers

FDRT-2024-293-3847

Identifier Type: -

Identifier Source: org_study_id