Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC

NCT05156970 | Completed Phase 2

• 1 other identifier: MA-HNC-II-002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in All Participants

  OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

  12 months

Secondary Outcomes (9)

• Progression Free Survival Per RECIST 1.1

  12 months

• Objective Response Rate Per RECIST 1.1

  12 months

• Duration of Response Per RECIST 1.1

  24 months

• ORR in Participants With PD-L1 CPS ≥1

  12 months

• ORR in Participants With PD-L1 CPS ≥20

  12 months

Study Arms (2)

Camrelizumab + Chemotherapy

EXPERIMENTAL

Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus cisplatin 75 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle (6 cycle maximum).

Drug: Camrelizumab; Drug: Cisplatin; Drug: Docetaxel; Drug: Carboplatin

Camrelizumab +Apatinib mesylate

EXPERIMENTAL

Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus Apatinib 250mg qd for up to 24 months.

Drug: Camrelizumab; Drug: Apatinib Mesylate

Interventions

Camrelizumab DRUG

Camrelizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months

Also known as: AiRuiKa™, SHR-1210

Camrelizumab + Chemotherapy; Camrelizumab +Apatinib mesylate

Cisplatin DRUG

Cisplatin 75 mg/m\^2 or Carboplatin AUC5 IV on Day 1 of each 3-week cycle (4 to 6 cycle maximum)

Also known as: Platinol

Camrelizumab + Chemotherapy

Docetaxel DRUG

Docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle (4 to 6 cycle maximum)

Also known as: DTX

Camrelizumab + Chemotherapy

Apatinib Mesylate DRUG

Apatinib 250mg qd for up to 24 months

Also known as: YN968D1

Camrelizumab +Apatinib mesylate

Carboplatin DRUG

Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum)

Also known as: Paraplatin

Camrelizumab + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma which is histologically or cytologically confirmed, and unable to be cured by local treatment (the primary site of the tumor is the oropharynx, oral cavity, hypopharynx and larynx), recurrence or metastasis stage did not receive any anti-tumor systemic therapy (allowed as part of the treatment of locally advanced tumors, and it has been more than 6 months from the end of treatment to signing the informed consent);
• ECOG score of 0 or 1;
• At least one measurable lesion according to RECIST1.1 criteria.
• Tumor tissue with PD-L1 detection (paraffin specimens or fresh tumor tissue within 2 years) can be provided; Patients with Oropharyngeal cancer should provide P16 detection status by using IHC method;
• Patients with a history of brain/meningeal metastasis must be treated with local therapy (surgery/radiotherapy) before the start of the study, and clinically stable for at least 3 months (corticosteroids are allowed before the first dose of the study drug, but need to be discontinued 2 weeks before the start of the study drug); The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

You may not qualify if:

• Progression within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma;
• Previous history of primary tumor of nasopharyngeal carcinoma;
• Intolerable to platinum-based therapy;
• Previous treatment with platinum-based regimen and disease progression;
• Patients who participated in or were participating in other drug/therapy clinical trials 4 weeks before the first dose of study drug;
• Patients who underwent major surgery or had not recovered from the side effects of this surgery; Patients who has accepted live vaccination, immunotherapy, or patients who underwent radiotherapy within 2 weeks;
• Patients who received any other anti-tumor treatment;
• Patients who are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment;
• History of other malignant tumors within the past 5 years, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, early prostate cancer and cervical carcinoma in situ;
• Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin and other treatments before the first dose of study drug;
• Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies or activating or inhibiting drugs against T cell receptors (e.g., OX40, CD137);
• Presence of active or uncontrolled metastatic central nervous system tumor lesions diagnosed by imaging;
• Positive test results for HIV antibody or Treponema pallidum antibody;
• Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components;
• Active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or history of active pulmonary tuberculosis;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 86, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; Cisplatin; Docetaxel; apatinib; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Chenping Zhang, M.D.

  the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: December 14, 2021
• Study Start: June 24, 2021
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)