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Trial record 1 of 1 for:    NCT04826679
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Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC

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ClinicalTrials.gov Identifier: NCT04826679
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Xuekui Liu, Sun Yat-sen University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Camrelizumab, nab-paclitaxel, cisplatin Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental

Camrelizumab + Cisplatin + Nab-paclitaxel

Camrelizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Cisplatin (IV), dose=60mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

 Drug: Camrelizumab, nab-paclitaxel, cisplatin

Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1.

Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Other Name: Camrelizumab and chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: 9 weeks ]
    overall response rate


Secondary Outcome Measures :
  1. pCR [ Time Frame: 9 weeks ]
    Pathological Complete Response

  2. MPR [ Time Frame: 9 weeks ]
    Major Pathological Response

  3. DCR [ Time Frame: 9 weeks ]
    Disease Control Rate

  4. PFS [ Time Frame: 2 years ]
    Progression-free survival

  5. OS [ Time Frame: 5 years ]
    overall survival

  6. Adverse events graded by CTCAE v5.0 [ Time Frame: 90 days after the first dose of study treatment ]
    Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04826679


Contacts
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Contact: xuekui Liu 13609713406 Liuxk@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: xuekui Liu    13609713406    Liuxk@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: xuekui Liu Sun Yat-sen University
More Information
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Responsible Party: Xuekui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04826679    
Other Study ID Numbers: OBU-GD1-BC-HNC-II-001
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action