A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Sun Yat-sen University
300 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
Summary
To compare whether AK104 combined with GP or PFLL can improve survival benefit, safety and tolerability in nasopharyngeal carcinoma patients who have failed first-line treatment; To compare the survival benefits of GP or GFLL treatment in nasopharyngeal carcinoma patients who had failed first-line therapy; To compare the survival benefits of GP or GFLL combined with AK104 in patients with nasopharyngeal carcinoma who had failed first-line therapy.
Eligibility
Plain Language Summary
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Interventions
Groups 1 and 2: Patients who have not been treated with PFLL in front-line therapy. 5-Fu:200mg/m2/d, d1-30, continuous intravenous infusion; Cisplatin: 80mg/m2, intravenous infusion for 4h, the first and 28th days of each cycle; AK104: 6mg/kg intravenous infusion for more than 60 minutes, used on days 1, 15, 30, 45 of each cycle, and administered 30 minutes before chemotherapy drugs during chemotherapy. Groups 3 and 4: Patients who had never used GP in their front-line treatment regimen. Gemcitabine: 1000mg/m2, used on the 1st and 8th day of each cycle; Cisplatin: 80mg/m2 on the first day of each cycle; AK104 6mg/kg intravenous infusion for more than 60 minutes was used on day 1, 15 (single cycle)/or day 8 (double cycle) of each cycle, and was administered 30 minutes before chemotherapy drugs during chemotherapy. Every 3 weeks is a treatment cycle, with a maximum of 6 cycles used. After 6 cycles of chemotherapy, both groups could continue to receive AK104 (once every 2 weeks).
Groups 1 and 2: Patients who have not been treated with PFLL in front-line therapy. 5-Fu:200mg/m2/d, d1-30, continuous intravenous infusion; Cisplatin: 80mg/m2, intravenous infusion for 4h, the first and 28th days of each cycle; placebo: 6mg/kg intravenous infusion for more than 60 minutes, used on days 1, 15, 30, 45 of each cycle, and administered 30 minutes before chemotherapy drugs during chemotherapy. Groups 3 and 4: Patients who had never used GP in their front-line treatment regimen. Gemcitabine: 1000mg/m2, used on the 1st and 8th day of each cycle; Cisplatin: 80mg/m2 on the first day of each cycle; placebo 6mg/kg intravenous infusion for more than 60 minutes was used on day 1, 15 (single cycle)/or day 8 (double cycle) of each cycle, and was administered 30 minutes before chemotherapy drugs during chemotherapy. Every 3 weeks is a treatment cycle, with a maximum of 6 cycles used. After 6 cycles of chemotherapy, both groups could continue to receive placebo (once every 2 weeks).
Locations(1)
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NCT06241599