Actively Recruiting
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody Toripalimab and CAPOX Chemotherapy for Locally Advanced Rectal Cancer
Led by Fudan University · Updated on 2025-02-21
46
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with locally advanced rectal cancer (LARC) characterized by specific tumor stages (T3-4/N+M0) and tumor location within 12 cm from the anal verge. This phase II, prospective, randomized trial aims to assess the pathological complete response (pCR) rate following combined therapies. Secondary goals include monitoring severe acute side effects, anal function, surgical complications, and survival rates over three years. Participants will receive MR-guided adaptive radiotherapy at a dose of 30 Gy administered in 6 fractions, combined with six cycles of the chemotherapy regimen CAPOX and the PD-1 antibody Toripalimab. There are two experimental groups: one receiving conventional pelvic radiotherapy and the other undergoing lymph node-sparing radiotherapy, both followed by total mesorectal excision (TME) surgery after total neoadjuvant therapy (TNT). Treatment dosing schedules include Toripalimab at 240 mg every three weeks, Oxaliplatin at 130 mg/m2 every three weeks, and Capecitabine at 1000 mg/m2 twice daily for 14 days every three weeks. During the study, participants will undergo regular assessments to monitor treatment effects, including pathological evaluation one month after surgery to determine pCR. Researchers will also track grade 3-4 adverse events from randomization until three months post-neoadjuvant therapy, anal function and local recurrence-free survival up to 36 months, as well as disease-free and overall survival rates over three years. Surgical complications will be evaluated within three months after surgery. The total duration of participation includes treatment, surgery, and follow-up assessments for up to three years.
CONDITIONS
Brief Title
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old, male or female
- Pathologically confirmed rectal adenocarcinoma
- Tumor located within 10 cm from the anal verge
- Clinical stage T3-4 and/or node-positive disease
- No distant metastases
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- Karnofsky performance score of 70 or higher
- Adequate organ function with no contraindications to surgery, radiochemotherapy, or immunotherapy
- No prior chemotherapy or other anti-tumor therapy
- No prior immunotherapy
- Good compliance expected during the study
- Signed informed consent form
You will not qualify if you...
- History of other malignancies within 5 years, except cured skin cancer or cervical cancer in situ
- Pregnancy or breastfeeding
- Uncontrolled epilepsy, central nervous system disease, or severe psychiatric disorders affecting consent or adherence
- Active serious heart disease, including recent myocardial infarction or severe heart failure
- History of organ transplantation requiring immunosuppressive or long-term hormone therapy
- Autoimmune diseases
- Severe uncontrolled infections or other serious concomitant illnesses
- Abnormal baseline blood and liver/kidney function tests outside specified limits
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Allergy to any component of the study drugs
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 18 weeks covering 6 cycles of chemotherapy and radiotherapy.
Participants receive combined pelvic radiotherapy with 6 cycles of CAPOX chemotherapy and PD-1 antibody immunotherapy.
Multiple visits over approximately 18 weeks corresponding to 6 cycles of treatment every 3 weeks
Duration - Surgery scheduled shortly after treatment completion, with post-operative care lasting up to 3 months.
Participants undergo total mesorectal excision (TME) surgery following neoadjuvant therapy and receive immediate post-operative care.
1 surgery visit and several post-operative visits within 3 months
Duration - Up to 36 months after surgery
Participants are monitored for pathological response, adverse effects, anal function, surgical complications, and survival outcomes for up to 36 months after surgery.
Periodic visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Z
Zhen Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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