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Classical Hodgkin LymphomaPhase 2NCT04067037

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

A Phase 2 study testing Camrelizumab, Epirubicin and Vincristine in people with Classical Hodgkin Lymphoma, run by Henan Cancer Hospital at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Classical Hodgkin Lymphoma
What is being tested?
Camrelizumab, Epirubicin and Vincristine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesChina
Study dates
26 Aug 2019to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 75 years old (including 18 and 75)
  • Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
  • Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
  • No receiving chemotherapy before enrollment
  • Having at least one measurable lesions
  • World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
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  • Life expectancy no less than 3 months
  • enough main organ function
  • 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
  • Agreeing to sign the written informed consents

Who cannot join

  • Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
  • Diagnosed as central nervous system lymphoma
  • usage of immunosuppressants before enrollment and the dose of immunosuppressant used >10mg / day oral prednisone for more than 2 weeks
  • Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
  • Active autoimmune disease
  • Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
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  • Serious surgery and trauma less than two weeks
  • Other malignant tumor history or active malignant tumor need be treated
  • Systemic therapy for serious acute/chronic infection
  • Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
  • Active tuberculosis
  • Vaccination with live attenuated vaccine less than 4 weeks
  • HIV-positive, AIDS patients and untreated active hepatitis
  • Researchers determine unsuited to participate in this trial

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • An Yang Tumor Hospital

    Anyang, Henan, 455000

  • The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Single-arm, Multi-center and Phase II Clinical Trial of Camrelizumab Combined With AVD (Epirubicin, Vincristine and Dacarbazine) in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

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.

Read the 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.

Being tested
Camrelizumab, Epirubicin, Vincristine, Dacarbazine
Keywords
Classical Hodgkin Lymphoma, PD-1/PD-L1 Signaling Pathway, Camrelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

    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.

  • EpirubicinDrug

    Also called Epirubicin hydrochloride

    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.

  • VincristineDrug

    Also called Oncovin

    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.

  • DacarbazineDrug

    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 groups in NCT04067037
Study groupRoleWhat they receive
Camrelizumab Combined With AVD regimenExperimentalCamrelizumab 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.
Receives: Drug: Camrelizumab; Drug: Epirubicin; Drug: Vincristine; Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

Secondary outcomes (5)

  1. objective response rate

    the total proportion of patients with complete response (CR) and partial response (PR)

    Measured: 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)

  2. 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.

    Measured: 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.

  3. 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

    Measured: 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)

  4. overall survival

    from date of first day of treatment to the date of death by any cause

    Measured: 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)

  5. 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

    Measured: from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start26 Aug 2019
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067037
Sponsor's protocol ID
HNSZLYY01
Status last verified
Jan 2026
First submitted
18 Aug 2019
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Epirubicin and Vincristine in people with Classical Hodgkin Lymphoma, run by Henan Cancer Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete metabolic response rate (CMRR) (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04067037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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