A Study of Intrapleural Administration of Bevacizumab and Camrelizumab for Malignant Pleural Effusion

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT05330065
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Malignant Pleural Effusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab and camrelizumab — DRUG
    Stage 1 was classical "3+3" dose escalation with pts assigned to one of the following 3 cohorts, Cohort A:Avastin 5mg/kg once every 2 weeks and camrelizumab 100mg once every 2 weeks;Cohort B:Avastin 7.5mg/kg once every 2 weeks and camrelizumab 100mg once every 2 weeks;Cohort C:Avastin 7.5mg/kg once every 2 weeks and camrelizumab 200mg once every 2 weeks.DLT was observed for 28 days.

Study Details

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 primarily considered as an immune and vascular manifestation of pleural metastases. The combined use of anti-angiogenic therapy and immunotherapy may be a promising strategy for MPE. This is a Phase Ib/II clinical trial to evaluate the safety and tolerability of administering bevacizumab and camrelizumab into the intrapleural space of subjects with malignant pleural effusion through a pleurX catheter.

Key Dates

Start date
Aug 1, 2022
Status verified
Apr 2022
Primary completion
Aug 31, 2023
Completion
Aug 31, 2024

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and Camrelizumab for Malignant Pleural Effusion

Primary Outcome Measure

Adverse Events (Safety) [ Time Frame: up to 12 months ]

Central Contacts

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