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Efficacy and Safety of Toripalimab Combined With AP-induced Chemotherapy Followed in Non-metastatic IVB Hypopharyngeal Cancer

NCT05860335 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-20

No results posted yet for this study

Summary

The goal of this type of study: single center exploratory clinical trial is to evaluate the efficacy and safety of Toripalimab combined with AP-induced chemotherapy followed by concurrent chemoradiotherapy and Toripalimab-maintenance therapy sequentially in patients with non-metastatic IVB hypopharyngeal cancer. The main question\[s\] it aims to answer are: • \[main objectives: to evaluate the objective remission rate (ORR), progression-free survival (PFS) and safety of PD-1 inhibitor Toripalimab combined with induction chemotherapy (cisplatin / nedaplatin + albumin paclitaxel) in patients with locally advanced head and neck squamous cell carcinoma according to RECISTv1.1.\] • \[Secondary objectives: 1-year, 2-year, 3-year progression-free survival rate (PFS); 1-year, 2-year, 3-year overall survival rate (OS); overall survival time (OS); tumor regression time; quality of life was evaluated by ECOG physical status and EQ-5D-5L assessment. \] \[Exploratory Objective: to explore the relationship between the biomarkers in tumor tissue and / or blood, including PD-L1 (CPS/TPS), HPV (P16), PD-1, TMB, EGFR, CD3, CD4, CD8, TP53, MSI-H and the efficacy of immunotherapy, and the relationship between MDM2/MDM4, EGFR, chromosome 11q13 interval (CCND1/FGF19/FGF3/FGF4) and immune hyperprogression\] Participants will \[be treated with Toripalimab injection (240mg/, once every 3 weeks) combined with cisplatin / nedaplatin (40mg) and albumin paclitaxel (230mg/m2, once every 3 weeks). The efficacy was evaluated within 1 week after induction therapy. In the phase of simultaneous radiotherapy, albumin paclitaxel (230mg/m2, once every 3 weeks, D1/D21/D43) was used. One month after the end of synchronous radiotherapy and chemotherapy, the efficacy was evaluated. After evaluation, all patients entered the next stage of immune maintenance therapy. During the maintenance phase, Toripalimabv injection (240mg/, once every 3 weeks) was given for 6 months or until the disease progressed, the toxicity was intolerable, the subjects asked to withdraw voluntarily, and the researchers judged that the subjects needed to withdraw from the study. The patients were treated with spiral tomographic radiotherapy (TOMO) or intensity modulated radiotherapy (IMRT).. These patients were given Nimotuzumab injection at the same time during simultaneous radiotherapy and chemotherapy.

Conditions

  • Hypopharyngeal Cancer

Interventions

DRUG

Cisplatin/Nedaplatin, albumin paclitaxel

During induction chemotherapy, triplelimab JS001 was administered before cisplatin/Nedaplatin and albumin paclitaxel. JS001 Intravenous infusion of cisplatin/Nedaplatin was administered 60 minutes after the end of infusion and beginning on day 1 of each cycle 40mg/m 2, D1, D2 albumin paclitaxel 230 mg/m 2; Chemotherapeutic drugs are administered in accordance with the drug label and local prodrome and other standard protocols for prophylactic use, every 3 Once a week (Q3W) for 2 cycles

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • China

Study Locations

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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 NCT05860335 on ClinicalTrials.gov