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Toripalimab in Combination With Chemotherapy as Induced Chemotherapy for Localized Hypopharyngeal Cancer

NCT04296747 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-05

No results posted yet for this study

Summary

60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the curative effect, and established an organ function preservation treatment strategy. Induction chemotherapy can reduce tumor burden and reduce distant metastases. At present, induction chemotherapy followed by concurrent chemoradiotherapy has become the standard treatment for the laryngeal preservation in locally advanced hypopharyngeal and laryngeal cancer. This study aimed to investigate the efficacy and safety of a PD-1 inhibitor toripalimab combined with chemotherapy as induction therapy in hypopharyngeal cancer.

Conditions

  • Hypopharyngeal Squamous Cell Carcinoma

Interventions

DRUG

induction chemotherapy

Toripalimab 240mg, d1; docetaxel 75mg/m2 d1; cisplatin 75mg/m2 d1, q21d, for 2 cycles

PROCEDURE

surgery

After induction chemotherapy, patients with resectable hypopharyngeal cancer would accept surgery within 2-4 weeks and investigator-selected postoperative treatment

RADIATION

chemoradiotherapy

After induction chemotherapy, patients with unresectable hypopharyngeal cancer who achieved CR/PR/SD in the tumor evaluation according to RECIST1.1 would accept another cycle of chemotherapy, and then radical chemoradiotherapy with cisplatin 100mg/m2, q21d

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Chunmei Bai · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2022-03-31
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296747 on ClinicalTrials.gov