WithdrawnNCT04806945Updated May 5, 2022

A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer

A Phase 3 interventional study of HLX10 and Paclitaxel in Cervical Cancer, sponsored by Shanghai Henlius Biotech. Withdrawn at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Shanghai Henlius Biotech (part of Fosun Pharma) · Phase 3, Interventional, and Treatment

Why this study was withdrawn

The sponsor terminated the trial.

Phase: Phase 3
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Female

Study summary

The purpose of this study is to assess the efficacy and safety of HLX10(Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) plus chemotherapy compared to the efficacy and safety of placebo plus chemotherapy in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.

The primary study hypotheses are that the combination of HLX10 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the IRRC or, 2) Overall Survival (OS).

Conditions studied

Cervical Cancer

Browse trials for

Uterine Cervical Neoplasms 1,927

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

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Lead sponsor

Shanghai Henlius Biotech is the lead sponsor of 131 studies on the registry; 55 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)
CPS≥1
Has measurable disease per RECIST 1.1 as assessed by IRRC
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
Has adequate organ function

Exclusion criteria

Exclusion Criteria:

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has received prior therapy with an anti-PD-1, anti-PD-L1 or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4）

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Experimental
HLX10
HLX10 + chemotherapy
Drug: HLX10 · Drug: Paclitaxel · Drug: Cisplatin · Drug: Carboplatin
Placebo comparator
Placebo
Placebo + chemotherapy
Drug: Paclitaxel · Drug: Cisplatin · Drug: Carboplatin · Drug: Placebo to HLX10

Interventions

DrugHLX10
IV infusion.
Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection
DrugPaclitaxel
IV infusion
DrugCisplatin
IV infusion
DrugCarboplatin
IV infusion
DrugPlacebo to HLX10
IV infusion

What researchers measure

Primary outcomes

Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Baseline until disease progression or death, whichever occurs first
Time frame: up to approximately 1 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years

Study locations

1 site

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2022; primary completion for Feb 2024, 16 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 17, 2021
First posted: Mar 19, 2021
StartEst.: Sep 30, 2022
Primary completionEst.: Feb 15, 2024
CompletionEst.: Oct 30, 2024
Last update: May 5, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04806945
Lead sponsor: Shanghai Henlius Biotech
Responsible party: Sponsor
First posted: Mar 19, 2021
Start date: Sep 30, 2022 (estimated)
Primary completion: Feb 15, 2024 (estimated)
Completion: Oct 30, 2024 (estimated)
Last update: May 5, 2022

Study contacts

lingying wu

principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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