Actively Recruiting
Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK）
Led by Dechang Diao · Updated on 2026-01-21
86
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safety and efficacy of Short-Course Radiotherapy Followed by Sequential Chemotherapy with or without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer. Complete Response (CR) Rate of Short-Course Radiotherapy Followed by Sequential Chemotherapy with or without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer.
CONDITIONS
Official Title
Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent form.
- Age 18 to 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy greater than 2 years.
- Histologically confirmed rectal adenocarcinoma.
- Tumor biopsy showing pMMR or genetic testing confirming MSS.
- Clinical stage II-III rectal cancer (cT3-4NanyM0 or cTxN+M0) with tumor 12 cm or less from the anal verge.
- Surgical evaluation confirming eligibility for curative-intent R0 resection.
- No prior systemic or local anti-cancer therapy for rectal cancer.
- Willingness to provide tumor tissue and blood samples for biomarker analysis.
- Adequate organ function.
- For women of childbearing potential: negative pregnancy test within 3 days prior to treatment and agreement to use highly effective contraception until 120 days after last study treatment.
- Willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other study requirements.
You will not qualify if you...
- Suspected metastatic lesions or locally advanced unresectable disease.
- History of other malignancies within 5 years except certain locally cured cancers.
- Participation in another interventional clinical trial.
- Acute complications requiring emergency surgery.
- Multiple primary rectal cancers.
- Prior pelvic or abdominal radiotherapy.
- Conditions impairing oral drug absorption.
- Prior systemic or local anti-tumor therapy for locally advanced rectal cancer.
- Recent use of non-specific immunomodulators or anti-tumor herbal medicines.
- Active autoimmune disease requiring systemic immunosuppression within 2 years.
- History of non-infectious pneumonitis or interstitial lung disease requiring steroids.
- Bleeding disorders or chronic anticoagulation.
- Uncontrolled comorbidities or psychiatric disorders affecting consent or compliance.
- Recent cardiac events or uncontrolled hypertension.
- Active inflammatory bowel disease or chronic diarrhea.
- Active severe infection requiring hospitalization or systemic antibiotics within 4 weeks.
- Recent major surgery or trauma within 30 days.
- Immunodeficiency or active tuberculosis or syphilis.
- Prior allogeneic organ or stem cell transplantation.
- Active hepatitis B or C without antiviral therapy.
- Live vaccines within 30 days or planned during study.
- Hypersensitivity to study drugs or monoclonal antibodies.
- Substance abuse or psychiatric disorders compromising compliance.
- Pregnancy or lactation.
- Conditions confounding efficacy or safety assessments or limiting survival evaluation.
- Other conditions deemed inappropriate by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 610655
Actively Recruiting
Research Team
D
Dechang Diao, Dr
CONTACT
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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