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

Last updated: June 1, 2022
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT04139135
HLX10-006-GCneo
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation in the clinical study; fully understands and is informed ofthe study and has signed the Informed Consent Form (ICF); willing to comply with andable to complete all trial procedures.
  2. The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 yearsold.
  3. Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
  4. Within 4 weeks prior to first dose, determined by the Independent Radiology ReviewCommittee (IRRC) as: ≥ T3 and number of lymph node metastases ≥ 1 and no distantmetastasis.
  5. Prior to enrollment, the attending physician will evaluate to determine theeligibility 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 thetumor tissues at screening or in the investigated surgery (if any), for PD-L1expression 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

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 priorto the first dose.
  4. Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogramshows: 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, radiationpneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
  8. Patients who have previously received other antibody/drug treatments for immunecheckpoints, such as PD-1, PD-L1, and CTLA4 treatments.
  9. Have diseases that may increase the risk of participating in the study and using thestudy medications, or other severe, acute, and chronic diseases and therefore arejudged by the investigator to be unsuitable for clinical studies.

Study Design

Total Participants: 642
Study Start date:
December 12, 2019
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Peking University shenzhen hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Affiliated Hospital of Hebei University

    Baoding,
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • China PLA General Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University International Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu,
    China

    Active - Recruiting

  • Cangzhou People's Hospital

    Cangzhou,
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi,
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang,
    China

    Active - Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan,
    China

    Active - Recruiting

  • Tianjin Medical University Institute & Hospital

    Tianjin,
    China

    Active - Recruiting

  • Xingtai People's Hospital

    Xingtai,
    China

    Active - Recruiting

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