Clinical Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT04922450 | Unknown Phase 2

• 1 other identifier: HNIC21
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

In this single-arm study, pathologically confirmed advanced head and neck squamous cell carcinoma will be enrolled to investigate the efficacy and safety of Camrelizumab in combination With albumin paclitaxel and cisplatin.

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma

Keywords

immunotherapy; PD-1 checkpoint inhibitor; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

• Clinical remission rate(CRR)

  the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

  immediately after the surgery

• Pathological remission rate(PRR)

  the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

  immediately after the surgery

Secondary Outcomes (2)

• 2-year survival rate, 2-year progression-free survival rate, 2-year recurrence-free survival rate, 2-year survival rate without distant metastasis

  2 year

• Adverse event rate

  2 year

Study Arms (1)

Camrelizumab，albumin paclitaxel and cisplatin.

EXPERIMENTAL

Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up.

Drug: PD-1 inhibitor; Drug: Albumin Paclitaxel; Drug: Cisplatin

Interventions

PD-1 inhibitor DRUG

Intravenous administration of SHR1210 (200mg/3weeks)

Camrelizumab，albumin paclitaxel and cisplatin.

Albumin Paclitaxel DRUG

Albumin Paclitaxel(260mg/m²),every 3 weeks

Camrelizumab，albumin paclitaxel and cisplatin.

Cisplatin DRUG

Cisplatin（80mg/m²）, every 3 weeks

Camrelizumab，albumin paclitaxel and cisplatin.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years, both men and women;
• Patients who diagnosed as Squamous cell carcinoma by pathological examination;
• Patients who have not received systemic or local treatment for head and neck squamous cell carcinoma;
• The primary tumor and lymph nodes can be completely surgically removed;
• Exclude distant metastasis through chest CT and full-body bone scanning;
• The patient's vital organs are functioning normally and can tolerate the specified treatment plan Absolute neutrophil count ≥1.8 × 109 / L platelets ≥100 × 109/L, Hemoglobin ≥9g/dL, serum albumin ≥3g/dL Bilirubin≤1.5 ULN ALT and AST≤2.5 ULN INR≤1.5 ULN leukocyte≥2000/L Serum creatinine ≤ 1.5 ULN Thyroid Stimulating Hormone≤ 1 ULN
• ECOG score：0-1
• Women of childbearing age (15-49 years old) have a negative serum or urine HCG test within 7 days before treatment, and agree to use medically approved measures for contraception during treatment and 120 days after treatment ends
• Males who have not been sterilized must agree to take effective contraceptive measures during the study period and at least 120 days after the last dose of PD-1 monoclonal antibody
• Patients can provide enough tissue samples for PD-L1 detection or exploratory research.
• The patient signs an informed consent and voluntarily participates in the clinical trial

You may not qualify if:

• Patients who pathologically confirmed non-squamous cell carcinoma
• Patients who has recurrence or distant metastasis
• Local lesions have been surgically removed
• Patients who have received systemic anti-cancer therapy, including hormone therapy
• Patients who have received treatment targeting PD-1 or PD-L1
• Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered)
• Controlled type 1 diabetes
• Hypothyroidism(If it can be controlled with hormone replacement therapy)
• Controlled celiac disease
• Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.
• Any other disease that is not expected to recur without external triggers
• Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer)
• Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.
• However, patients who have currently or previously used any of the following steroid regimens can be selected:
• Adrenaline replacement steroids(Prednisone ≤10mg/day or equivalent dose of similar drugs)

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hunan cancer Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Immune Checkpoint Inhibitors; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yaqian Han

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Wenxiao Huang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Hui Wang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaqian Han

CONTACT

18673176667; hanyaqiancs@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients fulfilling Eligibility Criteria will be included in our study.Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy.Treatments will be administrated until death, or unacceptable toxicity.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 10, 2021
• Study Start: January 20, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author of published work.

Locations

CN (1)