PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma

November 5, 2023 updated by: Shi Li，MD, Xijing Hospital

A Single-arm, Prospective, Phase II Study of PABLIXIMAB Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous-cell Carcinoma

The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma.

The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy.

Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The secondary questions it aims to answer are:

Objective response rate (ORR) after neoadjuvant therapy

  • R0 resection rate
  • major pathological remission (MPR) rate
  • organ preservation rate
  • event-free survival (EFS)
  • local recurrence-free survival (LRFS)
  • distant metastasis-free survival (DMFS)
  • quality of life score (QoL)
  • overall survival (OS)
  • incidence of adverse events (including neoadjuvant stage AEs and full course AEs) The exploratory question it aims to answer is: clearance of peripheral blood ctDNA.

Study Type

Observational

Enrollment (Estimated)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A otolaryngology patient at Xijing Hospital.

Description

Inclusion Criteria:

  1. age 18-80 years old, including 18 years old and 80 years old;
  2. MRI diagnosis of resectable stage III-IVA oropharynx, larynx and hypopharynx squamous-cell carcinoma confirmed by histopathology or cytology;
  3. ECOG PS score 0-1;
  4. the expression of PD-L1 was detected by immunohistochemistry (TPS and CPS score)
  5. having at least one measurable lesion according to RECIST version 1.1;
  6. expected survival time ≥6 months;
  7. The neutrophil count was ≥1.5 × 10^9/L, the platelet count was ≥100 × 10^9/L, the hemoglobin count was ≥90 g/L
  8. renal function was normal: serum creatinine ≤1.5×ULN;
  9. the liver function was basically normal: serum total bilirubin ≤1.5 × ULN, serum aspartate transaminase (AST)≤2.5×ULN, serum Alanine transaminase (ALT)≤2.5 ×ULN;
  10. female patients had to be negative for a urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) ;
  11. Sign the written informed consent.

Exclusion Criteria:

  1. patients were treated with anti-tumor drugs including but not limited to PD-1 inhibitor, CTLA-4 antibody, EGFR monoclonal antibody, EGFR-tki, and anti-angiogenesis drugs;
  2. History of autoimmune diseases including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, Rheumatoid Arthritis, inflammatory bowel disease, Antiphospholipid syndrome vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
  3. participated in other intervention clinical trials within 30 days before screening;
  4. history of other malignancies (except cured skin basal-cell carcinoma) ;
  5. the presence of serious and poorly controlled co-morbidities (e.g. heart failure, diabetes, hypertension, liver failure, kidney failure, thyroid disease, mental illness, etc.) ;
  6. Known to be infected with HIV or active hepatitis or tuberculosis;
  7. major surgery or planned surgery within 30 days before the first dose of the trial drug;
  8. Persons who are allergic to the use of drugs or their components in the programme;
  9. pregnancy (confirmed by blood or urine HCG testing) or lactation in women, or in subjects of reproductive age who were unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
  10. it is not suitable for the researcher to participate in this study;
  11. Unwilling to participate in the study or unable to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy.
Time Frame: About 50 days after the start of neoadjuvant immunotherapy.
pCR means that there are no residual living tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.
About 50 days after the start of neoadjuvant immunotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR(objective response rate)
Time Frame: At least 1 year.
Objective response rates after neoadjuvant immunotherapy were measured, usually as the proportion of patients whose tumor volume decreased by 30% and maintained over 4 weeks, that is, the sum of the rates of complete response (CR) and partial response (PR) , the higher the ORR, the more patients achieved tumor shrinkage with the treatment.
At least 1 year.
R0 resection rate
Time Frame: At least 1 year.
R0 resection is the highest standard of tumor resection, which means complete tumor resection with negative margin. The tumor R0 resection rate was calculated for the patients who underwent surgery after the completion of neoadjuvant immunotherapy.
At least 1 year.
MPR（major pathological response）
Time Frame: At least 1 year.
MPR is defined as the percentage of residual tumor cells in the tumor bed being less than or equal to 10% .
At least 1 year.
Overall survival rate
Time Frame: At least 1 year.
Overall survival is the proportion of all participants who survived the study period. Overall survival was calculated by dividing the number of people alive by the total number at the start of the study.
At least 1 year.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: At least 1 year.
Researchers should grade the severity of each adverse event. If the severity/intensity of an adverse event is not specified in the guidelines, the investigator can assess it based on the general definition of grade 1-5 and in conjunction with his or her medical judgment.
At least 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
clearance of peripheral blood ctDNA
Time Frame: At least 1 year.
ctDNA is circulating tumor DNA, also known as tumor DNA, which enters the bloodstream when tumor cells die or are released. It is a liquid biopsy method that detects the presence and associated changes of tumor cells in a blood sample.
At least 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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