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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWest China Second University Hospital

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary signing of a written ICF.

Age ≥18 years, ≤75 years, female.

The Eastern Cooperative Oncology Group (ECOG) physical fitness score was 0 or 1.

Expected survival ≥3 months.

Disqualifiers

Ovarian cancer of non-epithelial origin, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumors) , and low-malignant potential ovarian tumors (such as borderline tumors) .

Previous (within 5 years) or concurrent with other malignancies, the local tumors that have been cured (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer that has not recurred for more than 3 years after radical operation are excluded.

Local recurrence is suitable for patients undergoing surgery.

Previous radiation therapy of the abdomen and pelvis.

Trial design

Design model

Single group

Treatments tested in this trial

  • QL1706

    Drug

    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.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Defined as the proportion of subjects achieving optimal total efficacy (Bor) as confirmed Cr or PR (according to RECIST v1.1) . The best overall response was defined as the best response recorded (in order of CR, PR, SD, PD, or non-evaluable) from the beginning of treatment until disease progression, or in cases where PD was not achieved before the initiation of subsequent antitumour therapy or before study discontinuation (whichever occurred first) , the best efficacy was recorded (from the start of treatment until the last evaluable tumour imaging assessment) .

Time frame
up to 6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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