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New treatment option for Gastroesophageal-junction Cancer
Official title A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
ClinicalTrials.gov ID: NCT06532006
What this study is testing
What is HLX22?
HLX22 is an investigational medicine, being studied as a potential treatment for gastroesophageal-junction cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- ECOG PS within 7 days before randomization: 0-1.
You likely can't join if
- 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...
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) \< 55%.
See the full eligibility 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
- 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...
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) \< 55%.
- people who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Anaheim, California, United States
- Los Alamitos, California, United States
- Greeley, Colorado, United States
- Deerfield Beach, Florida, United States
- Fort Myers, Florida, United States
- Plantation, Florida, United States
- Pompano Beach, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Chicago, Illinois, United States
- Des Moines, Iowa, United States
- Iowa City, Iowa, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Sayre, Pennsylvania, United States
- Nashville, Tennessee, United States
- Abilene, Texas, United States
+ 147 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anaheim, California, United States; Los Alamitos, California, United States; Greeley, Colorado, United States; Deerfield Beach, Florida, United States; Fort Myers, Florida, United States; Plantation, Florida, United States and 161 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.