RecruitingPhase 2NCT06840665

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

A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

Sponsor

Fudan University

Enrollment

46 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

Age 18-70 years old, male or female
Pathologically confirmed rectal adenocarcinoma
The distance from anal verge ≤ 10 cm
Clinical stage T3-4 and/or N+
No evidence of distance metastases
MSI/MMR status: MSS/pMMR
Karnofsky score >=70
Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
No chemotherapy or any other anti-tumor therapy prior to enrollment
No immunotherapy prior to enrollment
With good compliance during the study
Signed written informed consent

Exclusion Criteria10

Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
Pregnancy or breast-feeding women
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
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
Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
Individuals with autoimmune diseases
Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
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
Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
Individuals allergic to any drug component of the study