Health TrialsbyHealthPanel

Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

ConditionMalignant Peritoneal Mesothelioma, Advanced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the study and voluntarily sign the informed consent form;

Age ≥18 years old;

Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;

ECOG performance status of 0-1;

Disqualifiers

Unable to adhere to the study protocol or procedures;

Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period;

Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer;

Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab, Bevacizumab , Pemetrexed , Cisplatin

    Drug

    Sintilimab: 200mg, bevacizumab: 7.5mg/kg, pemetrexed: 500mg/m2, cisplatin: 75mg /m2, Q3w. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria. After 6 cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

The time from the date of first administration of this regimen to the date of first documented disease progression or death due to any cause.

Time frame
36 months

Secondary outcomes

1

Overall Survival (OS)

The time from the initiation of the first dose of medication in a patient to death from any cause.

Time frame
36 months
2

Objective Response Rate (ORR)

The proportion of patients with a comfirmed complete response or patial response using RECIST1.1.

Time frame
36 months
3

Disease Control Rate (DCR)

The percentage of patients who have achieved complete response, partial response, and stable disease to the treatment, as defined by RECIST 1.1 criteria.

Time frame
36 months

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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