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Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma

NCT06170697 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-12-20

No results posted yet for this study

Summary

Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. This project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.

Conditions

Interventions

DRUG

Camrelizumab

200mg, iv, d1, q3w

DRUG

Cisplatin

80-100mg/m2, iv, q3w, 2-3 cycles in total

DRUG

Carboplatin

AUC 2, iv, q1w, 5-7 cycles in total

DRUG

Lobaplatin

30mg/m2, iv, q3w, 2-3 cycles in total

DRUG

Nedaplatin

25-30 mg/m2, iv, q1w, 5-7 cycles in total

RADIATION

Radiotherapy

PGTVp/PGTVnd 66-70Gy/2-2.2Gy/30-35F；PTV1 60Gy/1.8-2.0Gy/30-33F；PTV2 50Gy/1.8-20Gy/25-28F；Start 1-2 weeks after the start of immunotherapy, 1 time before the start of simultaneous chemotherapy, up to 3 times during the concurrent chemoradiotherapy

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jingbo Wang · Chinese academy of medical science, cancer hospital

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
2023-03-01
Primary Completion
2024-07-31
Completion
2025-07-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06170697 on ClinicalTrials.gov