Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Head and Neck Squamous Cell CarcinomaProgrammed Cell Death Receptor 1 (PD-1)ChemotherapyChemoradiotherapyInduction Treatment

Outcome Measures

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.
2 year

Secondary Outcomes (7)

Overall Survival (OS)
2 year
Locoregional Recurrence-Free Survival (LRFS)
2 year
Distant Metastasis-free survival (DMFS)
2 year
Objective Response Rate (ORR)
Through study completion, an average of 1 year
Incidence of Adverse Events
2 year
+2 more secondary outcomes

Study Arms (2)

Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab

EXPERIMENTAL

Participants receive three cycles of induction chemoimmunotherapy (tislelizumab + paclitaxel-cisplatin) before initiation of CCRT. During CCRT, participants receive two cycles of concurrent cisplatin. After completion of radiotherapy, participants receive additional 13 cycles of adjuvant tislelizumab.

Biological: TislelizumabDrug: PaclitaxelDrug: Cisplatin (75 mg/m2)Radiation: Intensity-Modulated RadiotherapyDrug: Cisplatin (80 mg/m2)

Concurrent Chemoradiotherapy

ACTIVE COMPARATOR

Participants receive standard-of-care CCRT, consisting of IMRT with a total dose of 70Gy and two cycles of concurrent cisplatin.

Interventions

TislelizumabBiological

* 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.

Also known as: Tevimbra

Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab

PaclitaxelDrug

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Fudan University
Otherlead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Xin Zhou, M.D.CONTACT+86 18017863989 zhoux1013@shca.org.cn

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

tislelizumabPaclitaxelCisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Central Study Contacts

Xin Zhou, M.D.

CONTACT

+8618017863989 zhoux1013@shca.org.cn

Xueguan Lu, M.D.

CONTACT

+8618121299382

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Professor

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 20, 2026

Study Start

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2029

You may not qualify if:

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 a history of allergy to any component of anti-PD-1 antibodies, paclitaxel-based drugs, or cisplatin.
Prior radiotherapy, chemotherapy, immunotherapy (including PD-1, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, cancer vaccines, etc.), or biological targeted therapy for the current hypopharyngeal/laryngeal/oropharyngeal cancer.
Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
Requirement for systemic treatment with corticosteroids (prednisone equivalent dose \> 10 mg/day) or other immunosuppressive agents within 2 weeks prior to the first dose of the study drug, except for topical use to manage local inflammation, prevent allergies, or manage nausea and vomiting. Other special cases should be discussed with the investigator. Inhaled or topical steroids and physiological doses of corticosteroid replacement for adrenal insufficiency (≤ 10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease.
Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.
Has a history of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
Has a history of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.
Has a history or CT evidence of active tuberculosis infection, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without formal treatment.
Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
Known history of drug abuse, alcohol abuse, or substance addiction
Pregnant or lactating women.
Other factors considered by the investigator that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring combined treatment, severely abnormal laboratory test values, family or social factors, or any other circumstances that may compromise subject safety or integrity of the study data.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab

Concurrent Chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab

Concurrent Chemoradiotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations