Sintilimab Combined With Chemotherapy and SBRT in Limited Metastatic Head and Neck Squamous Cell Carcinoma (LM-HNSCC) (LM-HNSCC)
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|ClinicalTrials.gov Identifier: NCT05136768|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2021
Last Update Posted : November 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma Metastases Immunotherapy Stereotactic Body Radiotherapy||Drug: Sintilimab Radiation: SBRT Drug: Platinum based chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single center, single arm, phase II clinical study|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||December 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: Single arm
Sintilimab combined with platinum-based chemotherapy and SBRT
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
Other Name: Tyvyt®
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.
Other Name: SABR
Drug: Platinum based chemotherapy
Platinum based single or doublet chemotherapy, one cycle every 3 weeks (Q3W), 4-6 cycles.
Other Name: chemotherapy
- Progression-free survival time (PFS) [ Time Frame: Up to 2 years ]PFS is defined as the duration from the starting date of per-protocol treatment to first progression of disease, death or closure of study.
- Overall survival time (OS) [ Time Frame: Up to 2 years ]OS was calculated from the starting date of per-protocol treatment to death from any cause.
- Objective response rate (ORR) [ Time Frame: Up to 1 years ]CR + PR rate according to the RECIST version 1.1 guidelines.
- Disease control rate (DCR) [ Time Frame: Up to 1 years ]CR + PR + SD rate according to the RECIST version 1.1 guidelines.
- Duration of disease response (DOR) [ Time Frame: Up to 2 years ]The time from the date of first identification of response (CR or PR) to progression/death (P/D).
- Time to progression of initial lesions (TPIL) [ Time Frame: Up to 2 years ]The time from the first date of per-protocol treatment to progression of baseline lesions or death.
- Time to progression of new lesions (TPNL) [ Time Frame: Up to 2 years ]The time from the first date of per-protocol treatment to the appearance of new lesion of tumor or death.
- Time to progression of non-irradiated lesions (TPNRL) [ Time Frame: Up to 2 years ]Duration from the first date of per-protocol treatment to the specific progression of non-irradiated lesion or death.
- Adverse events [ Time Frame: Up to 2 years ]Adverse event assessment according to NCI CTCAE 5.0, including AE, TEAE, SAE and irAE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136768
|Contact: Junlin Yi, MDfirstname.lastname@example.org|
|Contact: Jingbo Wang, MDemail@example.com|
|Cancer hospital, Chinese Academy of Medical Sciences|
|Beijing, China, 100021|
|Principal Investigator:||Junlin Yi, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|