Unresectable Advanced or Recurrent Gastric Cancer
Conditions
Interventions
Safety Part (Dose Escalation):
Level 0: Bevacizumab biosimilar (5 mg/kg every 2 weeks) + ramucirumab + paclitaxel. Level 1: Bevacizumab biosimilar (10 mg/kg every 2 weeks) + ramucirumab + paclitaxel.
Sponsors
Takeru Wakatsuk
Kensei Yamaguchi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age between 18 and 75 years. 2)Performance Status (ECOG) of either 0 or 1. 3)Patients with gastric cancer who are refractory to or intolerant of chemotherapy containing fluoropyrimidine-based agents and platinum-based agents, with a prior treatment history limited to one regimen. The use of nivolumab, trastuzumab, cetuximab, or similar agents during first-line therapy is not restricted. 4)Diagnosed with unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) and histologically confirmed as adenocarcinoma. 5)Possess measurable lesions. 6)Have adequate organ function. 7)Blood pressure is well-controlled (at the time of registration, using only one antihypertensive drug, excluding combination drugs,with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg). 8)Agree to use contraception. 9)Written informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1)Prior treatment history with paclitaxel, ramucirumab, or bevacizumab. 2)History of major surgery, including stoma creation or bypass surgery, within the past 28 days. 3)Presence of metastases to the central nervous system (brain, spinal cord, or meninges). 4)Use of warfarin, antiplatelet drugs, or direct oral anticoagulants (DOACs) while having a primary tumor. 5)History of active bleeding from gastric cancer or gastrointestinal ulcers within the past 3 months. 6)History of gastrointestinal perforation or fistula. 7)History of deep vein thrombosis, pulmonary embolism, portal vein thrombosis, or other severe venous thromboembolism within the past 3 months. 8)History of arterial embolism within the past 6 months. 9)History of hypertensive encephalopathy or hypertensive crisis. 10)Presence of deep ulceration associated with a risk of perforation in the primary lesion or other sites. 11)Severe ascites extending continuously from the pelvic cavity to the upper abdomen. History of paracentesis within the past 3 months or requiring regular paracentesis. 12)Difficulty in maintaining adequate oral intake. 13)Presence of active multiple primary cancers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety part: Incidence of Dose-Limiting Toxicity Expansion part:Incidence of Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) in the Safety Part 1.Overall Survival (OS), Progression-Free Survival (PFS), and Disease Control Rate (DCR) in Expansion part 2.Day 8 VEGF-A, Day 8 Free VEGF-A, Day 8 Antibody-Bound VEGF-A, Day 8 Change in Free VEGF-A, Day 8 Percentage Change in Free VEGF-A, VEGF-A at Each Time Point, Free VEGF-A at Each Time Point | — |
Contacts
Public ContactWakatsuki Takeru
Cancer Institute Hospital of JFCR
Outcome results
None listed