SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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
Eligibility criteria
Qualifiers
Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and institutional guidelines;
Patients with pMMR/MSS colorectal cancer;
Age between 18 and 75 years;
Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined as: 1. Pelvic MRI showing sacral infiltration at or above S2, 2. And/or lateral pelvic wall invasion, 3. And/or obturator vascular nerve infiltration, 4. After MDT discussion, there are no indications for a one-stage R0 resection, 5. The patient refuses total pelvic exenteration or debulking surgery);
Disqualifiers
Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);
Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;
History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;
Severe electrolyte abnormalities;
Trial design
Treatments tested in this trial
- Stereotactic Body Radiation Therapy (SBRT)
- PD1
- Chemotherapy
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor
Fudan University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Yunnan Cancer Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
Source ClinicalTrials.gov