Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 40 for:    Shanghai Henlius Biotech
Previous Study | Return to List | Next Study

A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150575
Recruitment Status : Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: HLX10+Albumin-Bound Paclitaxel Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: HLX10
HLX10+albumin-bound paclitaxel
Drug: HLX10+Albumin-Bound Paclitaxel
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.
Other Name: HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.




Primary Outcome Measures :
  1. ORR [ Time Frame: up to 2 years ]
    Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)


Secondary Outcome Measures :
  1. ORR [ Time Frame: up to 2 years ]
    Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively)

  2. PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years ]
    Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively)

  3. 6-month PFS rate [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months ]
    6-month progression-free survival rate

  4. OS [ Time Frame: from the date of first dose until the date of death from any cause,assessed up to 2 years ]
    Overall survival

  5. 6-month OS rate [ Time Frame: from the date of first dose until the date of 6-month ]
    6-month overall survival rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily participate and have signed the informed consent form (ICF);
  2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF
  3. Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
  4. Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. First-line chemotherapy includes any of the following:

    1. Platinum-based drugs + taxanes;
    2. Platinum-based drugs + topotecan;
    3. Taxanes + topotecan.
  5. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
  6. Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).
  7. An ECOG score of 0 or 1.
  8. Conforming to laboratory measurements;

Exclusion Criteria:

  1. Patients who have previously received albumin-bound paclitaxel.
  2. Patients with other active malignancies within 5 years or at the same time.
  3. Patients who are preparing for or have received an organ or bone marrow transplant.
  4. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  5. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.
  6. Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) < 50% by cardiac colour Doppler.

8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150575


Locations
Layout table for location information
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Shanghai Henlius Biotech
Investigators
Layout table for investigator information
Principal Investigator: lingying wu Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Layout table for additonal information
Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04150575    
Other Study ID Numbers: HLX10-011-CC201
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Disease Progression
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Disease Attributes
Pathologic Processes
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action