Multicenter, open, single-arm Clinical Study to Evaluate the Efficacy and Safety of Sintilimab Plus Chemotherapy (Cisplatin or Carboplatin+ Paclitaxel) as First-Line Treatment in Patients With Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma (R/M SCCHN)
- Conditions
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Registration Number
- ITMCTR1900002567
- Lead Sponsor
- Shanghai East Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Histologically- or cytologically-confirmed head and neck squamous cell carcinoma and no indications of local radical therapy.
2. At least one measurable lesion (based on RECIST1.1).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
4. Life expectancy of at least 3 months.
5. Can provide at least 20 pathological sections.
6. Adequate organs function.
7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study; For female subjects only, not pregnant or breastfeeding, and result of blood / urine pregnancy test (Within 7 days before the start of the study) should be negative.
8. Be willing to sign an informed consent form.
1. The primary tumor is squamous cell carcinoma of nasopharynx or skin.
2. Received systemic chemotherapy.
3. Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for local advanced HNSCC.
4. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
5. Diagnosed within 5 years or currently has other primary malignancy with the exception of cured carcinoma in situ of the cervixintramucosal carcinoma of gastrointestinal tractbreast and non-melanoma skin cancers and superficial bladder tumors.
6. Known untreated central nervous system (CNS) metastasis and/or carcinomatous meningitis.
7. Has peripheral neuropathy that is >= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
8. Previously had a severe hypersensitivity reaction to treatment with study drug or has a known sensitivity to any component of study drug, including severe hypersensitivity reaction >= Grade 3 (CTCAE v5.0) to monoclonal antibody, paclitaxel, carboplatin or cisplatin-related compounds.
9. Has active autoimmune disease that may worsen with the administration of an immunostimulant.
10. Use immunosuppressive drugs, except that:
11. History (current and past) of interstitial lung disease or non-contagious pneumonia with the exception of local interstitial pneumonia induced by radiotherapy;
12. Uncontrolled systemic diseases including diabetes, hypertension etc.
13. Any other active infection requiring systemic therapy, including active tuberculosis.
14. Uncontrolled pleural effusion, pericardial effusion or ascites.
15. Significant cardiovascular diseases such as heart failure of New York Heart Academy (NYHA) Grade 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval >= 480 ms) or unstable Angina.
16. History of immunodeficiency, including HIV positive or other, congenital / acquired immunodeficiency disease, or history of organ transplant.
17. Virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
a) HBsAg positive and HBV DNA titer >= 1000 copies /mL;
b) HCV antibody positive and HCV-RNA titer greater than the lower limit of detection.
18. Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the enrollment.
19. Receipt of any live vaccine within 4 weeks prior to the enrollment, but seasonal flu vaccines without live viruses are allowed.
20. Receipt of any investigational agent or used an investigational device within 4 weeks prior to the enrollment.
21. Any other condition that make the subject unfit to the study according to investigators judgement.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR;
- Secondary Outcome Measures
Name Time Method