Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
regorafenib, chemotherapy, Iparomlimab and Tuvonralimab
Brief summary
A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
Interventions
DRUGIparomlimab and Tuvonralimab combination with regorafenib and chemotherapy
Iparomlimab and Tuvonralimab：5mg/kg，Intravenous infusion，Q3W regorafenib：80mg，oral administration once daily from Day 1 to Day 14 chemotherapy：XELOX or SOX
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to participate in this study and has signed the informed consent form. * Age greater than 18 years, regardless of gender. * Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma. * No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease. * PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing. * At least one measurable lesion according to RECIST 1.1 criteria. * ECOG performance status 0-1. * Life expectancy \>3 months. * Adequate organ and marrow function:
Exclusion criteria
* Known HER2-positive expression (immunohistochemistry \[IHC\] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2). * Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted). * Known central nervous system metastases and/or carcinomatous meningitis. * Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction. * Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg). * History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0. * Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism. 8\. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 9\. Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | Up to approximately 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 2 years | — |
| Disease control rate (DCR) | Up to approximately 2 years | — |
| Duration of response (DoR) | Up to approximately 2 years | — |
| Overall survival (OS) | Up to approximately 5 years | — |
| The incidence and severity of adverse events (AE) during the study period (Safety) | Up to approximately 2 years | The incidence and severity of adverse events (AE) during the study period |
Contacts
Primary ContactHao Wu, Professor
Outcome results
None listed