Clinical trial NCT04826679: Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC
Official title: An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-04-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0（III-IV） head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel.

This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

Detailed description: In this study, eligible subject will be enrolled into study arm to accept study treatment. Objective response rate will be the primary outcome measures.

Eligibility criteria: Inclusion Criteria：

1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）
2. Greater than or equal to 18 and less than 65 years of age at time of study entry.
3. ECOG performance status of 0 or 1.
4. Resectable or potentially resectable lesion, without distance metastasis;
5. Measurable disease as per RECIST 1.1.
6. Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
7. Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL； 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3 x ULN)；AST/ALT ≤ 3 x ULN and ALP≤3 x ULN；ALB≥3g / dL；
8. Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

1. Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
2. Active, known or suspected autoimmune disease, including dementia and epilepsy.
3. Has had another known invasive malignancy or unresectable cancer.
4. Coagulation dysfunction: (PT \> 16S, APTT \> 53s, TT \> 21s, FIB \< 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
5. Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
6. Laboratory abnormality within 7 days before enrollment.
7. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
8. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
9. Has a known history of Human Immunodeficiency Virus (HIV).
10. Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
11. have received anti-tumor herbs within 4 weeks before randomization.
12. Pregnant or nursing women.

Primary outcomes:
measure: ORR
timeFrame: 9 weeks
Secondary outcomes:
measure: pCR
timeFrame: 9 weeks
measure: MPR
timeFrame: 9 weeks
measure: DCR
timeFrame: 9 weeks
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 5 years
measure: Adverse events graded by CTCAE v5.0
timeFrame: 90 days after the first dose of study treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: xuekui Liu
role: PRINCIPAL_INVESTIGATOR
References: