Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04164238

Enrollment

Registered

2019-11-15

Start date

2019-11-07

Completion date

2021-11-07

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC, PD-1 antibody, Neoadjuvant, Major pathologic response

Brief summary

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

Interventions

DRUGToripalimab

Toripalimab Injection

DRUGPaclitaxel

Paclitaxel Injection

DRUGCarboplatin

Carboplatin Injection

DRUGCisplatin

Cisplatin injection

DRUG5-fu

5-fu injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck; * Resectable or potentially resectable lesion; * ECOG PS 0-1; * Age \>18 years old; * At least one target lesion according to RECIST 1.1; * Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;

Exclusion criteria

* Distant metastasis; * Second malignancy within 5 years; * Nasopharyngeal carcinoma; * Active autoimmune diseases; * HIV infected; * Required prednisone dose \>=10mg daily; * Heart attack within 6 months; * Stroke within 6 months; * Other conditions that investigators consider the patients are not suitable for PD-1antibody;

Design outcomes

Primary

Measure	Time frame	Description
MPR	6 weeks	major pathologic response

Secondary

Measure	Time frame	Description
AE	2 years	adverse events
RFS	2 years	recurrence free survival
ORR	6 weeks	overall response rate
PFS	6 months	progression free survival

Countries

China

Contacts

Primary ContactYulong Zheng, MD

drzhengyu@126.com13588166206

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026