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

NCT04139135

Description:

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.

Related Conditions:
  • Gastric Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: HLX10-006-GCneo
  • NCT ID: NCT04139135

Conditions

  • Gastric Cancer

Interventions

DrugSynonymsArms
HLX10 100 mg in 10 ml InjectionSOX(oxaliplatin + tegafor gimeracil oteracil potassium (S-1))HLX10
PlacebosSOX(oxaliplatin 130 mg/m2/ 3W + tegafor gimeracil oteracil potassium (S-1))Placebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
HLX10ExperimentalHLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase
  • HLX10 100 mg in 10 ml Injection
PlaceboPlacebo ComparatorPlacebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.
  • Placebos

Eligibility 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 ≥10). 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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:3-year EFS rate
Time Frame:from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
Safety Issue:
Description:3-year event-free survival rate (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)

Secondary Outcome Measures

Measure:EFS
Time Frame:from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
Safety Issue:
Description:Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
Measure:DFS
Time Frame:from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years
Safety Issue:
Description:Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
Measure:pCR rate
Time Frame:after surgery,an average of 6 months
Safety Issue:
Description:Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
Measure:5-year OS rate
Time Frame:OS is the time from randomization to death (of any cause),assessed up to 5 years
Safety Issue:
Description:5-year overall survival (OS) rate

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shanghai Henlius Biotech

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