CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 21 target
Drug / intervention
HLX10+Albumin-Bound Paclitaxeldrug
Likely dose
HLX10+Albumin-Bound Paclitaxel 4.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04150575
NCT04150575Phase 2Unknown

A Single-Arm, Open-Label, Multicentre, Phase II Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

Shanghai Henlius Biotech·interventional·Posted Nov 5, 2019·Updated May 9, 2022

In Brief

A Phase 2 clinical trial evaluating HLX10+Albumin-Bound Paclitaxel for Cervical Cancer. Targeting 21 participants across 1 site.

Detailed Summary

This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and HLX10 for up to 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartMar 10, 2020
Primary CompletionJun 15, 2022
Study CompletionSep 15, 2022
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 6.7 years ago

Interventions

HLX10+Albumin-Bound Paclitaxeldrug

HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years.