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A Study of QL1706 (an Anti-PD-1/CTLA-4 Combined Antibody) Combined With Albumin-bound Paclitaxel and Bevacizumab in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

NCT06509971 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-07-19

No results posted yet for this study

Summary

* Major objectives To evaluate the efficacy of QL1706 combined with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer.
* Secondary Purpose To evaluate the safety of QL1706 in combination with albumin-binding paclitaxel and bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer.

Exploratory analysis of the association between the efficacy of the combination regimen and biomarkers.

Conditions

Interventions

DRUG

QL1706

The Order of Drug Administration was: QL1706→ bevacizumab → albumin-binding paclitaxel, and each drug was administered at least 30 minutes apart. QL1706: 5 mg/kg Q3W. The infusion time was 30 minutes + 5 minutes. No dose adjustment was allowed for QL1706 during treatment, but delayed administration was allowed, with a delay of no more than 4 weeks from the previous dose. Albumin-binding paclitaxel: 260 mg/m 2 Q3W, IV, for 30 min + 5 min. During treatment, albumin-binding paclitaxel allows for dose adjustments. Bevacizumab: 15 mg/kg Q3 W, iv. The first infusion should last 90 minutes. If the first infusion was well tolerated, the second infusion could be shortened to 60 minutes. If the patient is also well-tolerated for a 60-minute infusion, then all subsequent infusions can be completed in 30 minutes, no dose adjustment is allowed for bevacizumab.

Sponsors & Collaborators

  • West China Second University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-02-28
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509971 on ClinicalTrials.gov