Ivonescimab (AK112) Plus Paclitaxel as Second-line Therapy in Patients With Advanced G/GEJ Cancer
A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) Plus Paclitaxel Versus Paclitaxel With or Without Ramucirumab as Second-line Therapy in Subjects With Advanced Gastric or Gastroesophageal Junction(G.GEJ)Cancer Who Failed Immunochemotherapy
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
PFS
Time frame: 12-24 months
Secondary Endpoints
ORR
DCR
DoR
Eligibility Criteria
Inclusion Criteria: 1. Voluntary written informed consent provided 2. Age ≥18 and ≤75 years, regardless of gender 3. Histologically or cytologically confirmed advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma 4. Prior treatment failure with PD-1/L1 inhibitor combined with platinum-based chemotherapy; no other systemic antitumor therapy allowed (only first-line therapy permitted, with initial immunotherapy duration ≥12 weeks).Note: Patients who previously received adjuvant/neoadjuvant PD-1 inhibitor plus platinum-based chemotherapy for non-metastatic disease or curative-intent platinum chemoradiotherapy + PD-1 inhibitor for locally advanced or recurrent/metastatic disease are eligible if disease progression occurred within \<6 months after the last treatment and no subsequent systemic therapy was administered. 5. ECOG performance status of 0-1 6. Life expectancy ≥3 months 7. At least one measurable lesion per RECIST v1.1. Previously irradiated le…
Read full criteria on CT.gov →✦ Analyst Commentary
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