This is a prospective single-arm, multi-center and phase II clinical trial to observe the efficacy and safety of Camrelizumab combined with AVD in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
Hodgkin's lymphoma (HL) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (cHL). Currently, ABVD and BEACOPP are commonly used in the first-line treatment for cHL. There are about one third of patients, whose pre-treatment assessment are mainly advanced cHL, suffering relapse and drug resistance. PD-1/PD-L1 signaling pathway plays an important role in the development and progression of cHL. Nivolumab and Pembrolizumab have been used in the therapy in relapsed and refractory patients with cHL. Camrelizumab, a humanized anti-PD-1 IgG4 monoclonal antibody, is independently developed in China. The goal of our trial is to assess the efficacy and safety of Camrelizumab combined with AVD (Epirubicin, Vincristine and Dacarbazine) in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
200mg, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
35mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
1.4mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
An Yang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
complete metabolic response rate (CMRR)
the proportion of patients who achieved a complete metabolic response (CMR) as their best overall response (BOR) from the first dose of study treatment through the end-of-treatment (EOT) assessment
Time frame: every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
Time frame: every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)
duration of complete response(DoCR)
The time from the date of first documented complete response until the date of first documented disease recurrence, progression, or death from any cause, whichever occurs first.
Time frame: The time from the date of first documented complete response until the date of first documented disease recurrence, progression, or death from any cause, whichever occurs first, assessed up to 10 years.
2-year progression-free survival
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurrs first
Time frame: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days)
overall survival
from date of first day of treatment to the date of death by any cause
Time frame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 10 years (each cycle is 28 days)
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375mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations
Time frame: from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)