Actively Recruiting
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-23
31
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
S
Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy. Researchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival. Participants will: 1. Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy. 2. Visit the clinic once every 3 months for checkups and tests
CONDITIONS
Official Title
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent according to regulations
- Patients with pMMR/MSS colorectal cancer
- Aged between 18 and 75 years
- Tumor recurrence confirmed by histology, cytology, or imaging, assessed as unresectable by multidisciplinary team
- Locally recurrent rectal adenocarcinoma without clear distant metastasis or with resectable/controllable oligometastases
- No prior radiotherapy or completed initial radiotherapy over 6 months ago with dose less than 50.4Gy and no late bowel or bladder toxicity
- ECOG performance status 0-1
- Peripheral blood counts and liver/kidney function within specified normal ranges
- No history of other malignancies, not pregnant or breastfeeding, using effective contraception during study and 6 months after
- Expected survival of at least 12 months
You will not qualify if you...
- History of severe drug allergies including to platinum agents, 5-FU, LV, or 5-HT3 receptor antagonists
- Participation in other clinical trials within 4 weeks prior to enrollment
- Prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or other checkpoint therapies
- Severe electrolyte abnormalities
- Active gastrointestinal diseases with ulcers, bleeding, or perforation
- Recent history of arterial or deep vein thrombosis or bleeding tendency
- Pregnant or breastfeeding women or unwillingness to use contraception
- Brain metastases larger than 3cm or total volume over 30cc
- Spinal cord compression or tumors within 3mm of spinal cord
- Other active malignant tumors except certain treated cases
- Severe ECG abnormalities or recent coronary artery disease and heart failure NYHA class II or higher
- Active infections with fever over 38°C
- Poorly controlled hypercalcemia, hypertension, or diabetes
- Severe pulmonary diseases
- Mental disorders affecting treatment or CNS disease history
- Severe complications such as intestinal obstruction, renal or liver dysfunction, cerebrovascular disorders
- Unresolved grade 2 or higher toxicity from previous treatments except anemia, alopecia, and skin pigmentation
- Any unstable medical condition affecting safety or compliance
- Investigator deems patient unsuitable for trial participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510065
Actively Recruiting
Research Team
J
Jun Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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