Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed rectal adenocarcinoma;
With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;
Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;
No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；
Disqualifiers
Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;
Other malignancy history with disease free survival <5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;
Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies/mL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;
Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;
Trial design
Design model
Single group
Treatments tested in this trial
Sintilimab
DrugSintilimab+Hypofractionated radiotherapy
Hypofractionated Radiotherapy
RadiationHypofractionated Radiotherapy
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Adverse reaction
Adverse reaction after receiving treatment of Sintilimab combined with hypofractionated radiotherapy and perioperative complications
Time frame
up to 10 weeksSecondary outcomes
1
Pathological response rate
Pathological response rate after treatment
Time frame
6-8 weeks after radiotherapy2
Complete resection rate
Complete resection rate after treatment
Time frame
6-8 weeks after radiotherapy3
Quality of life questionnaire
Quality of life during treatment
Time frame
up to 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborator
Yunnan Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Chengdu Third People's Hospital
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
Source ClinicalTrials.gov