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

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ClinicalTrials.gov Identifier: NCT04139135
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Brief 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.

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

  • 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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: HLX10 Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: HLX10
HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase
Drug: HLX10
neoadjuvant treatment phase:HLX10(4.5mg/kg/3w IV) +SOX, adjuvant treatment phase:HLX10(4.5mg/kg/3w IV)
Other Name: Recombinant humanized anti-PD-1 monoclonal antibody injection

Placebo Comparator: Placebo
Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
Drug: Placebos
neoadjuvant treatment phase:placebos(4.5mg/kg/3w IV) +SOX, adjuvant treatment phase:SOX




Primary Outcome Measures :
  1. EFS [ Time Frame: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years ]
    event-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)


Secondary Outcome Measures :
  1. EFS [ Time Frame: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years ]
    Event-free survival (assessed by the investigator per RECIST v1.1 criteria)

  2. DFS [ Time Frame: from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years ]
    Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)

  3. pCR rate [ Time Frame: after surgery,an average of 6 months ]
    Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)

  4. 5-year OS rate [ Time Frame: OS is the time from randomization to death (of any cause),assessed up to 5 years ]
    5-year overall survival (OS) rate



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 years old.
  3. Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
  4. 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.
  5. Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.
  6. Have good cardiac function and can be treated with radical resection.
  7. 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.
  8. Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
  9. Expected survival 12 weeks;
  10. The functions of the vital organs meet requirements.

Exclusion Criteria:

  1. Existence of other active malignant tumors within 5 years or at the same time.
  2. Plan to perform or have undergone an organ or bone marrow transplant.
  3. Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
  4. Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
  5. Human immunodeficiency virus (HIV) infection.
  6. Patients with active tuberculosis.
  7. Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
  8. Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
  9. 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.

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): NCT04139135


Contacts
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Contact: Jiafu JI 010-88140650 jijiafu@hsc.pku.edu.cn
Contact: Lin Shen

Locations
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China, Guangdong
Peking University shenzhen hospital Recruiting
Shenzhen, Guangdong, China
Contact: Shu bin Wang    13823394076    Wangshubin2013@163.com   
Principal Investigator: Shu bin Wang         
China
Affiliated Hospital of Hebei University Recruiting
Baoding, China
Contact: Aimin Zang, MD         
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Jiafu JI    01088140650    jijiafu@hsc.pku.edu.cn   
China PLA General Hospital Recruiting
Beijing, China
Contact: Lin Chen, MD         
Peking University International Hospital Recruiting
Beijing, China
Contact: Jun Liang, MD         
Peking University Third Hospital Recruiting
Beijing, China
Contact: Baoshan Cao, MD         
The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, China
Contact: Congqiao Jiang, MD         
Cangzhou People's Hospital Recruiting
Cangzhou, China
Contact: Yuankai Bo, MD         
Anhui Provincial Hospital Recruiting
Hefei, China
Contact: Zhiqiang Zhu, MD         
Contact: Gang Wang, MD         
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, China
Contact: Guoping Sun, MD         
Linyi Cancer Hospital Recruiting
Linyi, China
Contact: Qingxu Sun, MD         
The Fourth Hospital of Hebei Medical University Recruiting
Shijia Zhuang, China
Contact: Yong Li, MD         
Shanxi Provincial People's Hospital Recruiting
Taiyuan, China
Contact: Xiaogang Bi, MD         
Tianjin Medical University Institute & Hospital Recruiting
Tianjin, China
Contact: Yi Ba, MD         
Xingtai People's Hospital Recruiting
Xingtai, China
Contact: Zhibin Huo, MD         
Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04139135    
Other Study ID Numbers: HLX10-006-GCneo
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases