Status:
UNKNOWN
A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Although Pembrolizumab plus trastuzumab and chemotherapy is the standard of care for first-line treatment of HER2-positive advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer,th...
Detailed Description
This study is a phase II, single arm study with main purpose to evaluate the safety, tolerability and efficacy of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-posi...
Eligibility Criteria
Inclusion
- Aged 18-75years (inclusive);
- Body weight ≥40 kg;
- Physical status score (ECOG score) 0-1;
- Expected survival \>12 weeks.;
- At least one measurable lesion (according to RECIST1.1);
- Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive G/GEJ cancer;
- HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor;
- Fail in previous first-line standard chemotherapy;
- prior therapy does not need to have included a HER2-directed therapy;
- Adjuvant or neoadjuvant therapy for AGC is allowed.
- Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy 8. Adequate hematological function defined by absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count ≥100 × 109/L, and hemoglobin ≥9 g/dL (blood transfusion before recruitment is allowed)
- Adequate hepatic function defined by a total bilirubin level ≤1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤2.5 × ULN 10. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) 11. Negative serum or urine pregnancy test at screening for women of childbearing potential 12. Fertile men and women must agree to take highly effective contraceptive precautions during, and for 6 months after the last dose of chemotherapy or for 1 month after the last dose of Tislelizumab
Exclusion
- An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
- Prior treatment with RC48, Fruquintinib, or apatinib either as single agents or as part of a treatment regimen.
- Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
- More than one prior line of therapy for advanced G/GEJ cancer;
- History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
- Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
- Peripheral neuropathy Grade \>/=2
- Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
- Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
- Clinically significant bleeding within 30 days before enrollment
- For female participants, current pregnancy or lactation
- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus
Key Trial Info
Start Date :
May 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 7 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05241899
Start Date
May 7 2022
End Date
May 7 2025
Last Update
February 16 2022
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052