Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

NCT ID: NCT04067037

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

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.

Conditions

Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab Combined With AVD regimen

Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

SHR-1210; Epirubicin hydrochloride; Oncovin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yanyan Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanyan Liu, M.D. Ph.D

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

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

Countries

China

Other Identifiers

HNSZLYY01

Identifier Type: -

Identifier Source: org_study_id