AzTrials
AzTrials

Gastric CancerPhase 3NCT04139135

A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

A Phase 3 study testing HLX10 in people with Gastric Cancer, run by Shanghai Henlius Biotech at 15 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
HLX10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
15 sitesChina
Study dates
12 Dec 2019to Oct 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
  • The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 years old.
  • Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
  • Within 4 weeks prior to first dose, determined by the Independent Radiology Review Committee (IRRC) as: ≥ T3 and number of lymph node metastases ≥ 1 and no distant metastasis.
  • Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.
  • Have good cardiac function and can be treated with radical resection.
Show all 10Show fewer
  • tumor specimen testing results are PD-L1 positive (CPS ≥5). Subjects must provide the tumor tissues at screening or in the investigated surgery (if any), for PD-L1 expression level assessment.
  • 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 requirements.

Who cannot join

  • Existence of other active malignant tumors within 5 years or at the same time.
  • Plan to perform or have undergone an organ or bone marrow transplant.
  • Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
  • Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
  • Human immunodeficiency virus (HIV) infection.
  • Patients with active tuberculosis.
Show all 9Show fewer
  • Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
  • Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
  • Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.

Trial locations and contacts

15 sites in 1 country.

Jiafu JI contact

010-88140650

jijiafu@hsc.pku.edu.cn

Lin Shen contact

15 sites in 1 country

China15 sites, 15 recruiting

  • Affiliated Hospital of Hebei University

    Baoding

    Aimin Zang, MD

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Jiafu JI, 01088140650, jijiafu@hsc.pku.edu.cn

    Recruiting

  • China PLA General Hospital

    Beijing

    Lin Chen, MD

    Recruiting

  • Peking University International Hospital

    Beijing

    Jun Liang, MD

    Recruiting

  • Peking University Third Hospital

    Beijing

    Baoshan Cao, MD

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Congqiao Jiang, MD

    Recruiting

  • Cangzhou People's Hospital

    Cangzhou

    Yuankai Bo, MD

    Recruiting

  • Anhui Provincial Hospital

    Hefei

    Zhiqiang Zhu, MD

    Gang Wang, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Guoping Sun, MD

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Qingxu Sun, MD

    Recruiting

  • Peking University shenzhen hospital

    Shenzhen, Guangdong

    Shu bin Wang, 13823394076, Wangshubin2013@163.com

    Shu bin Wang

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang

    Yong Li, MD

    Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan

    Xiaogang Bi, MD

    Recruiting

  • Tianjin Medical University Institute & Hospital

    Tianjin

    Yi Ba, MD

    Recruiting

  • Xingtai People's Hospital

    Xingtai

    Zhibin Huo, MD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer.

Subjects will be randomized to the following two arms at 1: 1 ratio:

Read more
  • Arm A (HLX10 arm): HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase;
  • Arm B (control arm): Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.

Chemotherapy regimen SOX (oxaliplatin + tegafor gimeracil oteracil potassium (S-1)) will be used in the neoadjuvant treatment phase in Arm A and B, and in the adjuvant treatment phase in Arm B.

After randomization, subjects will receive a total of 3 cycles of neoadjuvant treatment with the mentioned treatment regimen.Surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant treatment.All subjects who have completed the surgery will be unblinded after surgery, and adjuvant treatment will be started 3 to 12 weeks after surgery. Subjects randomized to Arm A (HLX10 arm) will continue to receive HLX10 monotherapy for up to 17 cycles (12 months).Subjects in Arm B after surgery (control arm) will continue to use chemotherapy alone (oxaliplatin + S-1) for 5 cycles.

Conditions
Gastric Cancer
Being tested
HLX10, Placebos
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • HLX10Drug

    Also called Recombinant humanized anti-PD-1 monoclonal antibody injection

    neoadjuvant treatment phase：HLX10（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：HLX10（4.5mg/kg/3w IV）

  • PlacebosDrug

    neoadjuvant treatment phase：placebos（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：SOX

Study groups in NCT04139135
Study groupRoleWhat they receive
HLX10ExperimentalHLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase
Receives: Drug: HLX10
PlaceboPlacebo comparatorPlacebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
Receives: Drug: Placebos

What is being measured

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

  1. EFS

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

    Measured: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years

Secondary outcomes (4)

  1. EFS

    Event-free survival (assessed by the investigator per RECIST v1.1 criteria)

    Measured: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 3 years

  2. DFS

    Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)

    Measured: from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years

  3. pCR rate

    Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)

    Measured: after surgery，an average of 6 months

  4. 5-year OS rate

    5-year overall survival (OS) rate

    Measured: OS is the time from randomization to death (of any cause)，assessed up to 5 years

Timeline

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

  1. First posted25 Oct 2019
  2. Study start12 Dec 2019
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2024 (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
642 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04139135
Sponsor's protocol ID
HLX10-006-GCneo
Status last verified
Jun 2022
First submitted
16 Oct 2019
Last updated
6 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shen L, Zhang X, Ji K, Lu L, Wang Q, Guan Q, Yan S, Zhou Y, Yang Y, Huo Z, You J, Ba Y, Ye Y, Chen Y, Wang S, Lv G, Zhang J, Hu X, Yang F, Yu H, Li J, Wang Q, Zhu J, Ji J; ASTRUM-006 Study Group. Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study. Lancet. 2026 Jun 20;407(10547):2542-2553. doi: 10.1016/S0140-6736(26)00974-8. Epub 2026 Jun 1.

    PubMed 42225112

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX10 in people with Gastric Cancer, run by Shanghai Henlius Biotech at 15 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 10 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Contact Jiafu JI (010-88140650, jijiafu@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFS (time frame: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years). 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 NCT04139135, which also lists 1 linked publication.

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 6 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in