NCT04164238

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2021

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 11, 2019

Last Update Submit

November 13, 2019

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCCPD-1 antibodyNeoadjuvantMajor pathologic response

Outcome Measures

Primary Outcomes (1)

  • MPR

    major pathologic response

    6 weeks

Secondary Outcomes (4)

  • AE

    2 years

  • RFS

    2 years

  • ORR

    6 weeks

  • PFS

    6 months

Study Arms (3)

Arm A

EXPERIMENTAL

Toripalimab 240mg IV, every 3 weeks;

Drug: Toripalimab

Arm B

EXPERIMENTAL

Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W

Drug: ToripalimabDrug: PaclitaxelDrug: Carboplatin

Arm C

EXPERIMENTAL

Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Cisplatin 25mg/m\^2 IV,d1-d3, Q3W; 5-FU 3000mg/m\^2 CIV 72h, Q3W

Drug: ToripalimabDrug: PaclitaxelDrug: CisplatinDrug: 5-fu

Interventions

ToripalimabDRUG

Toripalimab Injection

Arm AArm BArm C
PaclitaxelDRUG

Paclitaxel Injection

Arm BArm C
CarboplatinDRUG

Carboplatin Injection

Arm B
CisplatinDRUG

Cisplatin injection

Arm C
5-fuDRUG

5-fu injection

Arm C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

toripalimabPaclitaxelCarboplatinCisplatinFluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nong Xu, MD

    Zhejiang University

    STUDY CHAIR

Central Study Contacts

Yulong Zheng, MD

CONTACT

13588166206drzhengyu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 15, 2019

Study Start

November 7, 2019

Primary Completion

November 7, 2020

Study Completion

November 7, 2021

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

CN(1)