NCT07334431
Recruiting
Phase 1
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib/II Clinical Study
Interventionsfruquintinib＋trastuzumab + XELOX
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Henan Cancer Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Recommended Phase 2 doses (RP2Ds)
Overview
Brief Summary
This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have fully understood the study and voluntarily signed the informed consent;
- •18-75 years old (including 18 and 75 years old);
- •Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma;
- •No previous anti-tumor treatment for metastatic diseases;
- •HER2 positive;
- •Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- •Life expectancy ≥ 3 months;
- •At least one measurable lesion according to RECIST version 1.1;
- •The functions of vital organs met the following requirements (Blood components and cell growth factors were not allowed within 14 days before enrollment):
- •Absolute neutrophil count ≥1.5×109/L;
Exclusion Criteria
- •Failure to comply with the study protocol or study procedure;
- •Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors;
- •Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- •Known presence of symptomatic central nervous system metastasis or brain metastases;
- •Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;
- •Previously received allogeneic bone marrow transplantation or organ transplantation;
- •Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);
- •Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;
- •Subjects who are allergic to the investigational drug or any of its adjuncts;
- •Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
Arms & Interventions
fruquintinib＋trastuzumab + XELOX
Experimental
Intervention: fruquintinib＋trastuzumab + XELOX (Drug)
Outcomes
Primary Outcomes
Recommended Phase 2 doses (RP2Ds)
Time Frame: When the first cycle of treatment is completed（approximately 21 days）
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
PFS
Time Frame: Up to 3 years
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Secondary Outcomes
- OS(Up to 3 years)
- ORR(Up to 3 years)
- DCR(Up to 3 years)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority TrialNCT07261709Sun Yat-sen University236
Recruiting
Not Applicable
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell LymphomaNCT07270835The First Affiliated Hospital of Soochow University40
Recruiting
Phase 2
Multicenter, open-label, phase II study in patients with immunoglobulin M monoclonal gammopathy of unknown significance and Myelin Associated Glycoprotein antibodies related polyneuropathy and Zanubrutinib Treatment2023-505933-29-00University Medical Center Utrecht42
Recruiting
Phase 1/2
ELVN-002 combined with trastuzumab +/- chemotherapy in HER2 + Solid Tumors2023-509716-29-00Enliven Therapeutics Inc.156
Active, not recruiting
Phase 1
Trastuzumab Deruxtecan, and pembrolizumab in participants with Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer2023-509866-39-00Daiichi Sankyo Inc.76