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Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC

ConditionHPV-unrelated Head and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:

1. Does this treatment improve the survival outcomes of participants? 2. How do the tumors of participants response to the treatment? 3. How is the safety of this treatment? Researchers will compare this treatment (induction chemoimmunotherapy, followed by concurrent chemoradiotherapy, and then immunotherapy as maintenance therapy) to concurrent chemoradiotherapy to see whether it provides additional clinical benefits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed HPV-negative head and neck squamous cell carcinoma (including laryngeal, hypopharyngeal, or oropharyngeal cancer).

Loco-regionally advanced (Stage III-IVB) disease according to the 8th edition clinical staging system of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC).

Confirmed by a multidisciplinary team (MDT) as not amenable to curative surgery and deemed suitable for definitive concurrent chemoradiotherapy.

ECOG performance status of 0-1.

Disqualifiers

Has a history or presence of other malignancies, except for those that have been cured and with no evidence of disease for over 5 years (such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.).

Has active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism stabilized with thyroid hormone replacement therapy; type I diabetes mellitus stabilized on insulin regimen; vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood.

Has uncontrolled cardiac clinical symptoms or diseases, such as: (a) NYHA Class II or above heart failure; (b) unstable angina; (c) myocardial infarction within the past year; (d) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.

Has severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of the study drug, active infection during screening, or unexplained fever > 38.5°C before administration (tumor-related fever may be considered for inclusion).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Biological/Vaccine

    * As induction immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 3 cycles. * As adjuvant immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 13 cycles.

  • Paclitaxel

    Drug

    \- As induction chemotherapy, 175 mg/m2 administered IV infusion on Day 2 of each 21-day cycle, for 3 cycles.

  • Cisplatin (75 mg/m2)

    Drug

    \- As induction chemotherapy, 75 mg/m2 administered IV infusion on Day 2-4 of each 21-day cycle, for three cycles.

  • Intensity-Modulated Radiotherapy

    Radiation

    \- Definitive IMRT: 70Gy given in 35 fractions over 7 weeks

  • Cisplatin (80 mg/m2)

    Drug

    \- As concurrent chemotherapy, 80 mg/m2 administered IV infusion on Day 1-3 of each 21-day cycle, for two cycles.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumabExperimental treatment 5 interventions
Group B: Concurrent ChemoradiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Event-free Survival (EFS)

Defined as the time to the earliest occurrence of progressive disease that precluded chemoradiotherapy or prevented completion of chemoradiotherapy, disease recurrence, or death from any cause.

Time frame
2 year

Secondary outcomes

1

Overall Survival (OS)

Defined as the time from randomization to death due to any cause.

Time frame
2 year
2

Locoregional Recurrence-Free Survival (LRFS)

Defined as the time from randomization to the first documented event of local or regional recurrence.

Time frame
2 year
3

Distant Metastasis-free survival (DMFS)

Defined as the time from randomization to the first documented event of distant metastasis.

Time frame
2 year
4

Objective Response Rate (ORR)

Defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST). ORR will be evaluated after induction treatment, CCRT, and adjuvant immunotherapy, respectively.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: