Phase II Clinical Study of Sintilimab Combined With Platinum-based Chemotherapy and SBRT in the First-line Treatment of Limited Metastatic Head and Neck Squamous Cell Carcinoma

Jun-Lin Yi, MD1 site in 1 country50 target enrollmentDecember 2021

ConditionsHead and Neck Squamous Cell Carcinoma Metastases Immunotherapy Stereotactic Body Radiotherapy

InterventionsSintilimab SBRT Platinum based chemotherapy

DrugsSintilimab Platinum based chemotherapy

Overview

Phase: Phase 2
Intervention: Sintilimab
Conditions: Head and Neck Squamous Cell Carcinoma
Sponsor: Jun-Lin Yi, MD
Enrollment: 50
Locations: 1
Primary Endpoint: Progression-free survival time (PFS)
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety and efficacy of combination of Sintilimab and SBRT on the basis of platinum-containing chemotherapy as the first-line treatment of limited metastatic head and neck squamous cell carcinoma (LM-HNSCC).

Detailed Description

For patients with LM-HNSCC, the conventional first-line treatment is EXTREME regimen dominated systemic therapy. In the recent era, immunotherapy has emerged to be the paramount issue for cancer treatment. A series of high-quality clinical studies demonstrated that immunotherapy (such as PD1 inhibitor) with or without chemotherapy (depending on CPS status) offered significant survival benefits to patients with recurrent or metastatic (R/M) HNSCC and the toxicities were well tolerated, whereas the PFS was still dismal. SBRT is associated with initiating release of tumor antigens, promoting DC activation, activating APCs, priming CD8+ CTLs, leading to the potential of abscopal effect. Therefore, we hypothesized that adding SBRT to Sintilimab (a PD1 inhibitor) and platinum-containing chemotherapy as the first-line treatment may improve the PFS for limited metastatic head and neck squamous cell carcinoma (LM-HNSCC).

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

December 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jun-Lin Yi, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Jun-Lin Yi, MD

Vice director of Dept. Radiotherapy

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent before implementing any trial-related procedures;
•Male or female, age ≥18 years old;
•Histologically confirmed head and neck squamous cell carcinoma, which was diagnosed as initial stage IVC/M1(synchronous metastatic disease) according to the 8th edition of UICC/AJCC or previously treated head and neck tumor with newly occurred metachronous metastatic disease ;
•Pathological diagnosis of metastasis is not mandatory, but the clinical diagnosis needs to receive consent of MDT;
•The number of metastases is 1-10;
•PD-L1 expression is positive, CPS≥1;
•According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), at least one metastatic lesion is radiologically measurable;
•Newly-diagnosed HNSCC who has not received any treatment previously or HNSCC who has been diagnosed metastases for the first time after treatment;
•For patients who have received platinum-containing chemotherapy in the past, the interval between the new metastasis and the end of the last chemotherapy administration is at least 6 months;
•After a comprehensive radiological examination, at least one extracranial metastatic lesion with a maximum diameter of ≤ 5cm (which can be treated with SBRT);

Exclusion Criteria

•The primary site is squamous cell carcinoma of the nasopharynx or skin cancer.
•The number of metastases\>10;
•Patients who have been diagnosed with other malignant tumors within 5 years before the first administration and have not been cured (excluding radically cured skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically resected carcinoma in situ);
•Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration;
•Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
•Received systemic treatment with anti-tumor indications Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
•An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
•Administration of systemic steroid (not include nasal spray, inhalation or other local approach) within 7 days before the first administration of Sintilimab or any other ways of immunosuppression;
•Receiving Xenografts or allogeneic hematopoietic stem cell transplantation in the past;
•Allergic to component of research drugs or adjacent;