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Not yet recruitingNCT07893340PeMUpdated Oct 23, 2026

First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma

A Phase 2 interventional study of Sintilimab and Ipilimumab N01 in Peritoneal Mesothelioma and First-line Therapy, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as first-line treatment in patients with unresectable malignant peritoneal mesothelioma. Eligible patients will receive sintilimab plus ipilimumab N01 and bevacizumab until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons, with a maximum treatment duration of 24 months. The primary endpoint is progression-free survival (PFS).

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Conditions studied

  • Peritoneal Mesothelioma
  • First-line Therapy

Keywords

  • MPeM
  • Immunotherapy
  • CTLA4 inhibitor
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have fully understood the study and voluntarily signed the informed consent;
  • Age≥ 18 years, gender not restricted;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with an expected survival period of more than 3 months;
  • Metastatic or locally advanced unresectable peritoneal mesothelioma confirmed by pathology or histology;
  • At least one evaluable lesion (according to RECIST 1.1 criteria);
  • Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN), subjects with asymptomatic abnormalities of T3, FT3, or FT4 are eligible.
  • Adequately controlled blood pressure.
  • Have not received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) for unresectable advanced or metastatic peritoneal mesothelioma;
  • Laboratory test data within 7 days before screening (including 7 days) should meet the following requirements: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 9g/dL, total serum bilirubin ≤ 3 times the upper limit of normal (ULN); ALT and AST ≤ 5 x ULN; albumin ≥ 28g/L; serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50ml/min; INR≤1.5 x ULN, APTT≤1.5 x ULN; urinalysis showing urine protein \< 2+, for subjects with urine protein ≥ 2+ at baseline, a 24-hour urine collection must be performed and the 24-hour urine protein must be \< 1 g.
  • Fertile female must have a negative serum pregnancy test within 3 days before first dose.
  • Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate \< 1 %) from 7 days before first dose until 120 days after the last dose.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women, and women of childbearing age who have not taken adequate contraceptive measures;
  • Patients with a history of other malignant tumors within 5 years, except for those with a history of cured cervical carcinoma in situ or non-melanoma skin cancer;
  • Patients with the following severe or uncontrolled diseases: severe heart disease, unstable condition despite treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment; definite neurological or psychiatric disorders, including dementia or epileptic seizures; severe or uncontrolled infections; active disseminated intravascular coagulation, or patients with obvious bleeding tendencies;
  • Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.
  • Presence of any active autoimmune disease or history of autoimmune disease.
  • History of allogeneic haematopoietic stem-cell or solid-organ transplantation.
  • Hypertension uncontrolled by medication before enrollment, defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
  • Other conditions where the investigator deems the patient unsuitable for participation in this trial;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (estimated)

Study arms

  • Experimental
    Sintilimab + Ipilimumab N01 + Bevacizumab

    Each treatment cycle is 6 weeks. Sintilimab: 200 mg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Ipilimumab N01: 1 mg/kg IV, D1, Q6W (Day 1 of every 6 weeks) Bevacizumab: 15 mg/kg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

    Drug: Sintilimab · Drug: Ipilimumab N01 · Drug: Bevacizumab

Interventions

  • Sintilimab: 200 mg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

  • Ipilimumab N01: 1 mg/kg IV, D1, Q6W (Day 1 of every 6 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

  • Bevacizumab: 15 mg/kg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

06

What researchers measure

Primary outcomes

  1. PFS

    Progression-free survival

    Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months

Secondary outcomes

  1. ORR

    Objective response rate

    Time frame: The proportion of subjects achieving complete response (CR) or partial response (PR) among all enrolled subjects; assessed per RECIST 1.1 every 6 weeks until disease progression or death, assessed up to approximately 12 months

  2. DCR

    disease control rate

    Time frame: The proportion of subjects achieving CR, PR, or stable disease (SD) among all enrolled subjects; assessed per RECIST 1.1 every 6 weeks until disease progression or death, assessed up to approximately 12 weeks

  3. OS

    overall survival

    Time frame: From date of enrollment until the date of death from any cause, assessed up to approximately 36 months

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Study locations

1 site
  • Fudan University ShangHai Cancer Center
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 23, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Sep 30, 2030
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07893340
Lead sponsor
Fudan University
Responsible party
Xiaodong Zhu (chief physician, Fudan University) — Principal investigator
First posted
Oct 23, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Sep 30, 2030 (estimated)
Last update
Oct 23, 2026

Study contacts

Xiaodong Zhu
Contact
xddr001@163.com
18017312567

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sintilimab · Ipilimumab N01 · Bevacizumab

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