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

Zhejiang University logo

Zhejiang University

Status and phase

Unknown
Phase 2

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: Paclitaxel
Drug: Cisplatin
Drug: 5-fu
Drug: Carboplatin
Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04164238
ZJU20191451

Details and patient eligibility

About

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).

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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;

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Arm A
Experimental group
Description:
Toripalimab 240mg IV, every 3 weeks;
Treatment:
Drug: Toripalimab
Arm B
Experimental group
Description:
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Treatment:
Drug: Carboplatin
Drug: Paclitaxel
Drug: Toripalimab
Arm C
Experimental group
Description:
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
Treatment:
Drug: Cisplatin
Drug: 5-fu
Drug: Paclitaxel
Drug: Toripalimab

Trial contacts and locations

1

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Central trial contact

Yulong Zheng, MD

Data sourced from clinicaltrials.gov

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