Efficacy and Safety of Immunotherapy Combined With Neoadjuvant Chemotherapy in Patients With Locally Advanced HPV (-) Head and Neck Squamous Cell Carcinoma: a Phase II Clinical Trial

NCT ID: NCT04929067

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-04-01

Brief Summary

There are few clinical trials of chemotherapy combined with immunotherapy in the neoadjuvant stage of locally advanced head and neck squamous cell carcinoma. The "phase II clinical trial of efficacy and safety of immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma" carried out by our team will be an active exploration of the application of immunodrugs in the neoadjuvant stage of newly treated patients with locally advanced head and neck squamous cell carcinoma

Conditions

Efficacy and Safety of Immunotherapy Combined With Neoadjuvant Chemotherapy in Patients With Locally Advanced HPV (-) HNSCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunotherapy combined with neoadjuvant chemotherapy forlocally advanced HNSCC

Group Type: EXPERIMENTAL

immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma

Intervention Type: DRUG

immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma

Interventions

immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma

immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

2) Patients who have used immune checkpoint inhibitors (including PD-1, PD-L1, PD-L2 and CTLA-4 inhibitors) in the past;

3) At the same time, there were other malignant tumors which were not controlled or under treatment;

4) Patients with any severe and / or uncontrolled medical disease include:

• The patients who used at least two kinds of antihypertensive drugs still had poor blood pressure control (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg);

• Grade 1 or above myocardial ischemia or myocardial infarction and grade 2 or above congestive heart failure (NYHA classification);

• Sinus bradycardia; Or second degree or more atrioventricular block, or sinus arrest (except pacemaker installed); Arrhythmia (including QTc ≥ 480ms); It is necessary to use drugs known to prolong QTc interval, including antiarrhythmic therapy;

• Active or uncontrolled severe infection (≥ CTC AE grade 2 infection);

• Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral drugs;

⑥ Renal failure requiring hemodialysis or peritoneal dialysis;

⑦ History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;

⑧ The patients with diabetes had poor blood glucose control (FBG > 10mmol / L);

• Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0g;

5) Patients who received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment;

6) The imaging findings showed that the tumor formed deep ulcer, or had invaded important blood vessels, or the researchers judged that fatal massive hemorrhage might occur during the follow-up study;

7) Regardless of the severity, there are any signs or history of bleeding constitution; In the first 4 weeks, there was any bleeding or bleeding event ≥ CTC AE 3; There are unhealed wounds, ulcers or fractures;

8) In the first 6 months of the study, patients with arteriovenous thrombotic events such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred;

9) Patients with history of aneurysm / dissection;

10) Patients with history of epilepsy or ataxia of nervous system need treatment;

11) Those who have a history of psychotropic drug abuse and can't quit or have mental disorder;

12) Patients with history of peripheral nervous system diseases and muscle strength below grade 3;

13) Those who had participated in other anti-tumor drug clinical trials or were conducting other clinical trials within 4 weeks before enrollment;

14) They can not tolerate the drugs used in this project, including treprizumab, albumin, paclitaxel and cisplatin, or have a history of severe hypersensitivity to any component;

15) According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Zhejiang University

Identifier Type: -

Identifier Source: org_study_id