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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Sintilimab: 200mg, administered by intravenous infusion on the first day of each cycle, one cycle every 3 weeks (Q3W), with the maximum cycle of 17. Suspension of Sintilimab administration: patients's request, disease progression, researcher-evaluated SAE
At least one metastatic lesion is suitable for SBRT. If applicable, all metastatic lesions were allowed to be irradiated. Recommended dose: BED ≥ 80Gy. Dose fractionation is determined as per physician's discretion, generally depending on the location of irradiated lesion and the distance to surrounding OARs. Timing of SBRT: After completing at least 2 platinum-containing chemotherapy plus sintilimab treatments, SBRT can be started after assessing that there is no AE ≥ G2.
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, China
Progression-free survival time (PFS)
PFS is defined as the duration from the starting date of per-protocol treatment to first progression of disease, death or closure of study.
Time frame: Up to 2 years
Overall survival time (OS)
OS was calculated from the starting date of per-protocol treatment to death from any cause.
Time frame: Up to 2 years
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: Up to 1 years
Disease control rate (DCR)
CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: Up to 1 years
Duration of disease response (DOR)
The time from the date of first identification of response (CR or PR) to progression/death (P/D).
Time frame: Up to 2 years
Time to progression of initial lesions (TPIL)
The time from the first date of per-protocol treatment to progression of baseline lesions or death.
Time frame: Up to 2 years
Time to progression of new lesions (TPNL)
The time from the first date of per-protocol treatment to the appearance of new lesion of tumor or death.
Time frame: Up to 2 years
Time to progression of non-irradiated lesions (TPNRL)
Duration from the first date of per-protocol treatment to the specific progression of non-irradiated lesion or death.
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Platinum based single or doublet chemotherapy, one cycle every 3 weeks (Q3W), 4-6 cycles.
Time frame: Up to 2 years
Adverse events
Adverse event assessment according to NCI CTCAE 5.0, including AE, TEAE, SAE and irAE.
Time frame: Up to 2 years