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

Launched by FUDAN UNIVERSITY · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called NeoPulsar, is studying a new treatment approach for locally advanced rectal cancer, which is cancer that has spread to nearby tissues but not to distant organs. In this trial, patients will receive a combination of special radiation therapy, a type of immunotherapy called Toripalimab, and chemotherapy known as CAPOX. The main goal of the study is to see how many patients achieve a complete response, meaning their cancer may be undetectable after treatment. The researchers will also monitor any serious side effects, how well patients recover after surgery, and the long-term success of the treatment.

To be eligible for this trial, participants must be between 18 and 70 years old and have a confirmed diagnosis of rectal cancer that meets specific criteria. They should not have received any previous treatments for cancer and must have a good level of overall health. If chosen to participate, patients can expect to receive the new treatment and be closely monitored throughout the study. This trial is currently recruiting participants, so if you or someone you know is interested, it may be a good opportunity to explore new treatment options.

Gender

ALL

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