Status:
UNKNOWN
A Study of Intrapleural Administration of Bevacizumab and Camrelizumab for Malignant Pleural Effusion
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Malignant Pleural Effusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with a variety of malignancies can develop malignant pleural effusion (MPE). MPE can cause significant symptoms and result in a marked decrease in quality of life and a poor prognosis. MPE is...
Detailed Description
This study is a phase Ib/II, single arm study with main purpose to evaluate the safety, tolerability and efficacy of intrapleural administration of bevacizumab and camrelizumab in subjects with malign...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Be ≥ 18 years of age on day of signing informed consent.
- Histologically or cytologically documented malignant pleural effusion
- Histologically confirmed cancer
- Malignant pleural effusion clinically judged as not responsive to conventional systemic therapy(ies) for primary malignancy
- Adequate liver and renal function as defined below:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of \> 12 weeks
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
- Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to have additional serum pregnancy tests during the study.
- Willing and able to comply with all study procedures
- Exclusion Criteria：
- Receiving any investigational agent, or using an investigational device, currently or within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is longer.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1, or who has not recovered to, ≤ Grade 1 toxicity at baselines from adverse events due to agents administered more than 4 weeks earlier.
- Has received prior intrapleural administration with an anti-programmed cell death receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has received prior intrapleural administration with bevacizumab or Endostar.
- Any concurrent chemotherapy, intraperitoneal (IP), biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgery within 28 days prior to day 1 of study treatment from which the patient has not completely recovered.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a history of non-infectious pneumonitis that required steroids; currently active non-infectious pneumonitis; or evidence of interstitial lung disease.
- Has an active infection requiring systemic therapy or history of uncontrolled infection.
- Concurrent disease or condition which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
- Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05330065
Start Date
August 1 2022
End Date
August 31 2024
Last Update
April 15 2022
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