Camrelizumab: 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.
Epirubicin: 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.
Vincristine: 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.
Dacarbazine: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
3. Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to sign the written informed consents
Exclusion Criteria:
1. Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
2. Diagnosed as central nervous system lymphoma
3. usage of immunosuppressants before enrollment and the dose of immunosuppressant used \>10mg / day oral prednisone for more than 2 weeks
4. Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
5. Active autoimmune disease
6. Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
7. Serious surgery and trauma less than two weeks
8. Other malignant tumor history or active malignant tumor need be treated
9. Systemic therapy for serious acute/chronic infection
10. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
11. Active tuberculosis
12. Vaccination with live attenuated vaccine less than 4 weeks
13. HIV-positive, AIDS patients and untreated active hepatitis
14. Researchers determine unsuited to participate in this trial
Primary outcome measure(s)
complete metabolic response rate (CMRR) — 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) 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
Trial sites (3)
Facility
City
Region
Status
An Yang Tumor Hospital
Anyang
Henan
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang
Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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