Malignant Peritoneal Mesothelioma, AdvancedPhase 2NCT06543069
Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
A Phase 2 study testing Sintilimab, Bevacizumab , Pemetrexed , Cisplatin in people with Malignant Peritoneal Mesothelioma, Advanced, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Peritoneal Mesothelioma, Advanced
- What is being tested?
- Sintilimab, Bevacizumab , Pemetrexed , Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Expected survival of ≥3 months;
- Function of vital organs must meet the following criteria (use of any blood products and cell growth factors is not allowed within 14 days prior to enrollment): Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90g/L; Total bilirubin <1.5 times the upper limit of normal (ULN); ALT and AST <2.5×ULN, GPT ≤1.5×ULN; Serum creatinine ≤1×ULN; Creatinine clearance rate >60 ml/min (Cockcroft-Gault formula);
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication; for men, must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication;
- Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -
Who cannot join
- 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;
- Previous allogeneic bone marrow or organ transplantation;
- Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction;
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- Allergy to study drugs or any of their excipients;
- International Normalized Ratio (INR) >1.5 or Partial Thromboplastin Time (APTT) >1.5×ULN;
- Electrolyte abnormalities of clinical significance as judged by the investigator;
- Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding >30 mL, including hematemesis, melena, hematochezia), hemoptysis (more than 5 mL of fresh blood within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attack) within the past 12 months;
- Significant cardiovascular diseases of clinical importance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart failure New York Heart Association (NYHA) class >2; ventricular arrhythmias requiring medication; Left Ventricular Ejection Fraction (LVEF) <50%;
- Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2);
- Known Human Immunodeficiency Virus (HIV) infection. Clinically significant liver disease history, including viral hepatitis [active Hepatitis B Virus (HBV) infection must be excluded, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known Hepatitis C Virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL)];
- Any other diseases, clinically significant metabolic dysfunctions, physical examination findings, or laboratory findings that, in the judgment of the investigator, make the patient unsuitable for the study drug (e.g., requiring treatment for epilepsy), could interfere with the interpretation of study results, or place the patient at high risk;
- Urinalysis indicating urine protein ≥2+ and 24-hour urine protein >1.0g;
- Complications requiring long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (more than 10mg/day of prednisone or equivalent therapeutic hormones);
- Patients deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital,Chinese Academy of Medical Sciences
Beijing
Yongkun Sun, 13141276041, hsunyk@cicams.ac.cn
About this study
Official title: A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma
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.
Read the detailed description
This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma. Enrolled patients will undergo treatment with sintilimab (200 mg), bevacizumab (7.5 mg/kg), pemetrexed (500 mg/m^2), and cisplatin (75 mg/m^2) administered every three weeks. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria, and after six cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. The primary outcome measure of the study is Progression-Free Survival (PFS), while secondary outcomes include Overall Survival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR).
- Being tested
- Sintilimab, Bevacizumab , Pemetrexed , Cisplatin
- Keywords
- Sintilimab, Bevacizumab, Pemetrexed, Cisplatin, Malignant Peritoneal Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab, Bevacizumab , Pemetrexed , CisplatinDrug
Also called Sintilimab+Bevacizumab+Pemetrexed+ Cisplatin
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin Receives: Drug: Sintilimab, Bevacizumab , Pemetrexed , Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
Overall Survival (OS)
The time from the initiation of the first dose of medication in a patient to death from any cause.
Measured: 36 months
Objective Response Rate (ORR)
The proportion of patients with a comfirmed complete response or patial response using RECIST1.1.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start31 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Peritoneal Mesothelioma, AdvancedStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongkun Sun, Doctor, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesCancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543069
- Sponsor's protocol ID
- NCC4469
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma
- ClinicalTrials.gov ID
- NCT06543069
- Acronym / sponsor ID
- NCC4469
- Keywords
- Sintilimab, Bevacizumab, Pemetrexed, Cisplatin, Malignant Peritoneal Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma. Enrolled patients will undergo treatment with sintilimab (200 mg), bevacizumab (7.5 mg/kg), pemetrexed (500 mg/m^2), and cisplatin (75 mg/m^2) administered every three weeks. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria, and after six cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. The primary outcome measure of the study is Progression-Free Survival (PFS), while secondary outcomes include Overall Survival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Sintilimab, Bevacizumab , Pemetrexed , CisplatinSintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Expected survival of ≥3 months;
Key exclusion criteria (18 listed)
- 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;
- Previous allogeneic bone marrow or organ transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab, Bevacizumab , Pemetrexed , CisplatinAlso: Sintilimab+Bevacizumab+Pemetrexed+ CisplatinSintilimab: 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. | Drug | single arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 36 months
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: 36 months
Objective Response Rate (ORR)
Time frame: 36 months
Disease Control Rate (DCR)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongkun Sun, Doctor study chair
Cancer Institute and Hospital, Chinese Academy of Medical SciencesCancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Bevacizumab , Pemetrexed , Cisplatin in people with Malignant Peritoneal Mesothelioma, Advanced, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Yongkun Sun (13141276041, hsunyk@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.