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A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma

ConditionAdvanced Soft-tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who were pathologically confirmed soft tissue sarcoma (soft tissue sarcomas other than alveolar/embryonal rhabdomyosarcoma, clear cell sarcoma, extraosseous Ewing sarcoma, alveolar soft tissue sarcoma, well differentiated liposarcoma, extraosseous myxoid chondrosarcoma, etc.)

The patient was diagnosed as progressive and the investigators determined that the lesion was not suitable for surgical treatment

The patients had not received systemic therapy (including chemotherapy, targeted therapy and bioimmunotherapy) for advanced soft tissue sarcoma. More than 6 months have passed since the end of neoadjuvant/adjuvant therapy (including chemotherapy, targeted therapy, bioimmunotherapy, etc.), and the cumulative dose of adriamycin used in the past was ≤100 mg/m2

In patients with measurable disease, lesions are defined and monitored by RECIST v1.1

Disqualifiers

known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components

Known allergy to recombinant humanized anti-CTLA-4 monoclonal antibody drug and its components

known allergy to any component of the cadonilimab formulation

Patients with cardiac disease class II or higher as determined by the New York Heart Association (NYHA) score

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Drug

    injectable solution

  • Adriamycin

    Drug

    injectable solution

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: cadonilimab (AK104) with adriamycinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

objective response rate (ORR)

ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and iRECIST

Time frame
from the first drug administration up to two years

Secondary outcomes

1

Disease control rate (DCR)

Proportion of patients whose best overall response is either CR, PR, or SD

Time frame
from the first drug administration up to two years
2

Duration of response (DOR)

Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

Time frame
from the first drug administration up to two years
3

Progression-free survival (PFS)

Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first

Time frame
from the first drug administration up to two years
4

Overall survival (OS)

Time from the date of first study treatment administration to the date of death due to any cause

Time frame
from the first drug administration up to two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Sun Yat-Sen University Cancer Center

Collaborator

Yunnan Cancer Hospital

Collaborator

The Affiliated Hospital Of Guizhou Medical University

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Xiangya Hospital of Central South University

Collaborator

Source ClinicalTrials.gov
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