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Esophageal Squamous Cell CarcinomaPhase 3NCT03958890

A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

A Phase 3 study testing HLX10 100 mg in 10 ml Injection in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Henlius Biotech at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.This study consists of three periods… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
HLX10 100 mg in 10 ml Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
489 participants
Where
7 sitesChina
Study dates
19 Jun 2019to 30 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who meet all of the following criteria are allowed to be enrolled into this study:
  • Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
  • Age ≥ 18 years and ≤ 75 years when ICF is signed;
  • Never received systemic anti-tumor drug therapy before.Exception: for patients who have received neoadjuvant/adjuvant treatment, the time from the last treatment to recurrence or progression can be screened for more than 6 months;For patients who have received radical concurrent chemoradiotherapy or radiotherapy for esophageal cancer, the time from the last chemotherapy/radiotherapy to the recurrence or progression time is more than 12 months.
  • According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the center image with at least one measurable lesions (such as esophageal cavity structure not as measurable lesions), measurable lesions should be not received radiotherapy, etc (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion);
  • PD-L1 positive subjects (CPS 1%).The subject must provide tumor tissue for pd-l1 expression level determination;
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  • Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
  • Expected survival 12 weeks;
  • The functions of the vital organs meet the following requirements (no blood transfusion, cytokine growth factor, or platelet raising drugs are allowed within 14 days before the first use of the study drugs); H. Absolute neutrophil count (ANC) ≥1.5 109/L I. platelet≥ 100 109/L; J. Hemoglobin≥ 9g/dL; K. Serum albumin≥ 3.0g/dL; L. Total bilirubin≤ 1.5 ULN, ALT, AST and/or ALP≤ 2.5 ULN;ALT and/or AST≤ 5 ULN in the presence of liver metastasis;If there is liver metastasis or bone metastasis ALP≤ 5 ULN; M. Serum creatinine ≤1.5 ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault formula); N. APTT, INR and PT ≤1.5 ULN;
  • For fertile female subjects, the serum pregnancy test must be negative within 7 days before the first dose.With fertile women subjects, and the partner for childbearing age women of male subjects, needs during the therapy, and after the last use HLX10 / placebo at least 3 months and the last time to use at least 6 months after chemotherapy using an approved by the medical contraception (such as intrauterine device, the pill or condoms);
  • Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.

Who cannot join

  • Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
  • 1. BMI < 17.5kg /m2;
  • 2. A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration;
  • 3. Obvious invasion of tumor into adjacent organs (aorta or trachea) of esophageal lesions leads to high risk of bleeding or fistula;3. Subjects after endotracheal stent implantation;
  • 4. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • 5. Previous allergies to monoclonal antibody, HLX10, 5-fu, cisplatin and other platinum drugs;
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  • 6.Have received any of the following treatments: A. Previous treatment with anti-pd-1 or anti-pd-L1 antibodies; B. Have received any research drugs within 4 weeks before the first use of the study drugs; C. Be enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or a follow-up interventional clinical study; D. Receive the final anticancer treatment within 4 weeks before the first use of the study drug;Palliative radiotherapy for bone metastases was allowed and was completed 2 weeks before the first dose.Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days before the first dose.
  • Subjects who require systemic treatment with corticosteroids (> 10 mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to the first use of the study drug;In the absence of active autoimmune disease, inhalation or topical use of steroids is permitted, and the therapeutic dose of prednisone 10mg/ day is allowed.
  • Those who have received the anti-tumor vaccine or the live vaccine within 4 weeks before the first dose of the study drug; G. Have undergone major surgery within 28 days prior to the first use of the study drug. Major surgery in this study is defined as requiring at least 3 weeks of postoperative recovery time before being able to receive the surgery treated in this study.Tumor puncture or lymph node biopsy were allowed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Ethics Committeeof cancer hospital, Chinese academy of medical sciences,

    Beijing, Beijing Municipality, 100021

  • the second Hospital of Jilin University

    Changchun, Jilin

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The first Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • the affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

Being tested
HLX10 100 mg in 10 ml Injection, Placebos
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX10 100 mg in 10 ml InjectionDrug

    3mg/kg IV（HLX10+cis-platinum+5FU）

  • PlacebosDrug

    3mg/kg IV（placebo+cis-platinum+5FU）

Study groups in NCT03958890
Study groupRoleWhat they receive
HLX10ExperimentalNot described
Receives: Drug: HLX10 100 mg in 10 ml Injection
placeboPlacebo comparatorNot described
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)

    Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

  2. OS

    Overall survival (OS)

    Measured: from the date of first dose unitl the date of death from any cause，assessed up to 2 years

Secondary outcomes (3)

  1. PFS

    Progression-free survival (assessed by independent radiological review committee (IRRC) based on iRECIST，by the investigators based on RECIST v1.1))

    Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

  2. ORR

    Objective response rate (assessed by independent radiological review and the investigators based on RECIST v1.1))

    Measured: up to 2 years

  3. Duration of response

    Duration of response

    Measured: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start19 Jun 2019
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
489 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03958890
Sponsor's protocol ID
HLX10-007-EC301
Status last verified
Apr 2023
First submitted
20 May 2019
Last updated
18 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gao J, Song Y, Kou X, Tan Z, Zhang S, Sun M, Zhou J, Fan M, Zhang M, Song Y, Li S, Yuan Y, Zhuang W, Zhang J, Zhang L, Jiang H, Gu K, Ye H, Ke Y, Qi X, Wang Q, Zhu J, Huang J. The effect of liver metastases on clinical efficacy of first-line programmed death-1 inhibitor plus chemotherapy in esophageal squamous cell carcinoma: A post hoc analysis of ASTRUM-007 and meta-analysis. Cancer Med. 2024 May;13(10):e7203. doi: 10.1002/cam4.7203.

    PubMed 38769930

  • Liu S, Jiang N, Dou L, Li S. Cost-effectiveness analysis of serplulimab plus chemotherapy in the first-line treatment for PD-L1-positive esophageal squamous cell carcinoma in China. Front Immunol. 2023 May 4;14:1172242. doi: 10.3389/fimmu.2023.1172242. eCollection 2023.

    PubMed 37215110

  • Song Y, Zhang B, Xin D, Kou X, Tan Z, Zhang S, Sun M, Zhou J, Fan M, Zhang M, Song Y, Li S, Yuan Y, Zhuang W, Zhang J, Zhang L, Jiang H, Gu K, Ye H, Ke Y, Li J, Wang Q, Zhu J, Huang J; ASTRUM-007 investigators. First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial. Nat Med. 2023 Feb;29(2):473-482. doi: 10.1038/s41591-022-02179-2. Epub 2023 Feb 2.

    PubMed 36732627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX10 100 mg in 10 ml Injection in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Henlius Biotech at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03958890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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