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Trial Title:
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
NCT ID:
NCT06532006
Condition:
Gastroesophageal-junction Cancer
Monoclonal Antibody
Gastric Cancer
HER2-positive Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Pembrolizumab
Trastuzumab
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HLX22
Description:
HLX22 15mg/kg Q3w
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 200mg q3w
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin 130 mg/m2 ,Q3W
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W
Arm group label:
Control group
Arm group label:
Experimental group
Summary:
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study
designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and
chemotherapy as first-line treatment in patients with HER2-positive locally
advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction
(G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio.
Enrolled subjects shall be treated with the study drug until the loss of clinical
benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons
specified by the protocol (whichever occurs first).
Detailed description:
In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo
(for pembrolizumab), once every 3 weeks (Q3W).
In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ±
pembrolizumab, Q3W.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male/female who are at least 18 years of age on the day of signing the informed
consent.
2. With histologically or cytologically confirmed diagnosis of previously untreated,
locally advanced unresectable or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma.
3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target
lesion must not be a bone metastatic lesion only.
4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or
FISH, as assessed by a central laboratory on a primary or metastatic tumor.
5. ECOG PS within 7 days before randomization: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function
Exclusion Criteria:
1. Patients with other malignant tumors within 2 years before the randomization.
2. Evidence of disease progression within 6 months (before randomization) after
completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy
for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
3. Previous treatment with any HER2-target therapy.
4. Active gastrointestinal bleeding
5. Presence of central nervous system (CNS) metastases.
6. Left ventricular ejection fraction (LVEF) < 55%.
7. Subjects who had known history of severe allergy to any monoclonal antibody or any
component of study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Investigator:
Last name:
Lin Shen
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Shanghai Henlius Biotech
Agency class:
Industry
Source:
Shanghai Henlius Biotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532006
