A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- 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.
- ECOG PS within 7 days before randomization: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
Exclusion criteria
- Patients with other malignant tumors within 2 years before the randomization.
- 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.
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) < 55%.
- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06532006
Intervention or treatment
DRUG: HLX22
DRUG: Pembrolizumab
DRUG: Trastuzumab
DRUG: Oxaliplatin
DRUG: Capecitabine
Conditions
- Gastroesophageal-junction Cancer
- Monoclonal Antibody
- Gastric Cancer
- HER2-positive Gastric Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
St. Vincent Hospital Melbourne
Select from list below to view details:
St. Vincent Hospital Melbourne
Fitzroy, Melbourne, Australia
Peninsula Health-Frankston hospital
Frankston, Melbourne, Australia
University of the Sunshine Coast Clinical Trials, Sunshine Coast Haematology and Oncology Clinic
Sunshine Coast, Queensland, Australia
GenesisCare Research
Campbelltown, Sydney, Australia
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Who is running the clinical trial?
Shanghai Henlius Biotech
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Experimental group
| Drug: HLX22, Drug: Trastuzumab, Drug: Oxaliplatin, Drug: Capecitabine |
ACTIVE_COMPARATOR: Control group
| Drug: Pembrolizumab, Drug: Trastuzumab, Drug: Oxaliplatin, Drug: Capecitabine |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm | Up to 5 years |
| Overall Survival （OS） | OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm. | Up to 5 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| PFS per RECIST 1.1 assessed by investigator | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm | Up to 5 years |
| Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 | ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm. | Up to 5 years |
| Adverse events (AE) | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm. | Up to 5 years |
References
Clinical Trials Gov: A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric CancerOther trials to consider
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