NCT04929067
Active, not recruiting
Phase 2
Immunotherapy Combined With Neoadjuvant Chemotherapy in Patients With Locally Advanced HPV (-) Head and Neck Squamous Cell Carcinoma
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country39 target enrollmentStarted: August 1, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Clinical complete response rate for participants after receiving immunotherapy combined with neoadjuvant chemotherapy
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients voluntarily participated in the clinical trial and signed the informed consent;
- •Histologically and pathologically confirmed locally advanced (stage Ⅲ - Ⅳ b) and HPV (-) head and neck squamous cell carcinoma. The primary tumor sites included oral cavity, oropharynx, larynx and hypopharynx;
- •The newly diagnosed patients did not receive any anti-tumor treatment ;
- •At least one measurable lesion (RECIST v1.1);
- •PS score was 0-1;
- •The main organ function met the following criteria within 7 days before treatment ① Blood routine examination standard (without blood transfusion within 14 days) Hemoglobin (HB) ≥ 90g / L; Absolute neutrophil count (ANC) ≥ 1.5 × 10\*9/L；Platelet count (PLT) ≥ 80 × 10\*9/L；② Biochemical test standard: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; Serum creatinine (CR) ≤ 1.5 ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; ③ Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%);
- •Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; Serum or urine pregnancy test was negative within 7 days before study enrollment. Male patients should agree to use contraception during the study period and within 6 months after the end of the study period.
Exclusion Criteria
- •Patients with carcinoma of nasal cavity and paranasal sinuses, nasopharyngeal carcinoma and HPV (+) oropharyngeal carcinoma;
- •Patients who have used immune checkpoint inhibitors (including PD-1, PD-L1, PD-L2 and CTLA-4 inhibitors) in the past;
- •At the same time, there were other malignant tumors which were not controlled or under treatment;
- •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;
Arms & Interventions
Immunotherapy combined with neoadjuvant chemotherapy forlocally advanced HNSCC
Experimental
Intervention: immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma (Drug)
Outcomes
Primary Outcomes
Clinical complete response rate for participants after receiving immunotherapy combined with neoadjuvant chemotherapy
Time Frame: 5 year
Secondary Outcomes
- Progression free survival(5 year)
- Overall survival(5 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(5 year)
- Major pathological response rate for the patients who received radical surgery(5 year)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer PatientsNon-small Cell Lung CancerNCT04941417Peking Union Medical College60
Recruiting
Phase 2
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell CarcinomaNeoadjuvant TherapyEsophageal Squamous Cell CarcinomaNCT06354530Army Medical Center of PLA266
Recruiting
Phase 2
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon CancerColon NeoplasmNCT05914389Second Affiliated Hospital, School of Medicine, Zhejiang University100
Not yet recruiting
Phase 2
Comparison of chemotherapy before and after definitive chemotherapy-radiotherapy with definitive chemotherapy-radiotherapy alone in patients with advanced cervical cancerIRCT20211011052730N1Shahid Beheshti University of Medical Sciences35
Active, not recruiting
Not Applicable
Phase I/II-Studie zur neoadjuvanten Chemotherapie mit nicht-pegyliertem liposomalem Doxorubicin, Paclitaxel und Lapatinib bei Patientinnen mit HER2-überexprimierenden, primärem MammakarzinomeEUCTR2007-000924-42-DESana Klinikum Lichtenberg