Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04297995
Brief Summary:
Part1:
A mutilpe-center, open-label, Phase II clinical trial to evaluate the efficacy and the safety of HLX10 in combination with HLX07 in patients with advanced advanced head and neck tumors.
Part2:
A randomized, double-blind, multi-center, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 in combination with HLX07 and chemotherapy versus HLX10 in combination with placebo and chemotherapy in the first-line treatment of R/M HNSCC.
Detailed Description:
Part 1:
This is an open label study. Sample size recommendations for this phase II study are determined according to Simon's two-stage Optimal design.
In the first stage, 13 patients will be accrued. The patients will receive 3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly (stage 1L). These patients will be assessed for treatment response after 8 weeks of first infusion of study drugs. If there are 3 or fewer responsive patients in these 13 patients, additional 13 patients will be accrued. These additional 13 patients will receive 3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly (Stage 1H). If 3 or fewer responses after eight weeks treatment noted in these 13 patients in stage 1H, the trial will be stopped.
If 4 or more patients are responsive to therapy in stage 1, the trial will be continued to stage 2, 30 additional patients will be accrued to reach a total of 43 patients. These additional 30 patients will receive the same dose of regimen as the prior patients.
Part 2:
This is a randomized, double-blind, multi-center, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 in combination with HLX07 and chemotherapy versus HLX10 in combination with placebo and chemotherapy in the first-line treatment of R/M HNSCC. Approximately 75 first-line R/M HNSCC subjects are planned to be recruited. The sample size calculation is not based on the statistical hypothesis.
Eligible subjects after screening will be randomly assigned to the treatment group (group A) or the control group (group B) in a ratio of 2:1, with PD-L1 CPS (≥ 20 and \< 20) as the stratification factor at randomization (Figure 1):
Group A: approximately 50 subjects, HLX10 in combination with HLX07 and chemotherapy (cisplatin in combination with 5-FU).
Group B: approximately 25 subjects, HLX10 in combination with placebo and chemotherapy (cisplatin in combination with 5-FU).
Cisplatin may be replaced with carboplatin when the subject is judged intolerant to cisplatin by the INV.
The study will be unblinded overall for ORR analysis approximately 3 months after the first dose of the last subject.
Study:
NCT04297995
Study Brief:
Protocol Section:
NCT04297995