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.
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
Interventions
Drug | Synonyms | Arms |
---|
HLX10 | Recombinant humanized anti-PD-1 monoclonal antibody injection | HLX10 |
Placebos | | 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
Name | Type | Description | Interventions |
---|
HLX10 | Experimental | HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase | |
Placebo | Placebo Comparator | Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase. | |
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: | Recruiting |
Lead Sponsor: | Shanghai Henlius Biotech |
Last Updated
August 6, 2020