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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06170697
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg, iv, d1, q3w
  • Cisplatin — DRUG
    80-100mg/m2, iv, q3w, 2-3 cycles in total
  • Carboplatin — DRUG
    AUC 2, iv, q1w, 5-7 cycles in total
  • Lobaplatin — DRUG
    30mg/m2, iv, q3w, 2-3 cycles in total
  • Nedaplatin — DRUG
    25-30 mg/m2, iv, q1w, 5-7 cycles in total
  • Radiotherapy — RADIATION
    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

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Jul 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy
    patients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy.

Primary Outcome Measure

1 year Progression-free survival (1y-PFS) [ Time Frame: up to 1 years ]

Central Contacts

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