Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma

NCT04440917 | Unknown Phase 2

• 1 other identifier: 2020HNRT01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (CR+PR)

  Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

  9 weeks

Secondary Outcomes (3)

• Number of Participants With at Least One Grade 3-4 Toxicity

  9 weeks

• Overall Survival

  2 years

• Progression-Free Survival

  2 years

Study Arms (1)

Study group

EXPERIMENTAL

Inductive therapy with Camrelizumab and Apatinib

Drug: Camrelizumab; Drug: Apatinib Mesylate

Interventions

Camrelizumab DRUG

200mg, iv, on day 1, 15, 29, 43

Also known as: Humanized anti-PD-1 inhibitor

Study group

Apatinib Mesylate DRUG

250 mg po, qd, 28 days as a cycle, 2 cycles in total

Also known as: VEGFR inhibitor

Study group

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed squamous cell or poorly differentiated or undifferentiated cancer of the head and neck (the primary sites include oral cavity, oropharynx, hypopharynx, larynx, nasal cavity and sinuses);
• Clinical stage of III-IVb (AJCC 2018);
• Surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy;
• Measurable disease;
• Eastern cooperative oncology group performance status (ECOG PS) score: 0-1;
• Blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/L, platelets\> 80,000/mm3；Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal; Renal function: serum creatinine \<1.5 times the upper limit of normal;
• Sign the informed consent.

You may not qualify if:

• Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
• Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
• Has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
• Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
• Patients undergoing therapy with other investigational agents;
• Women who are pregnant or breastfeeding;
• Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guopei Zhu, M.D.

CONTACT

021-23271699; antica@gmail.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

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: June 3, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 2, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)