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SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）

ConditionUnresectable Locally Recurrent Rectal Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)

    Radiation

    Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday.

  • PD1

    Drug

    The PD-1 monoclonal antibody used is Sintilimab 200mg every 3 weeks

  • Chemotherapy

    Drug

    First-line chemotherapy regimen of rectal cancer, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: SBRT+PD1Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

1 year PFS

1 year Progression-Free Survival Rate

Time frame
1 year

Secondary outcomes

1

1 year OS

1 year Overall Survival Rate

Time frame
1 year
2

ORR

Overall Response Rate

Time frame
1 year
3

DCR

Disease Control Rate

Time frame
1 year
4

R0 resection rate

R0 resection rate in participants

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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