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NCT06904300PHASE2NOT_YET_RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
Gastric (Cardia, Body) Cancer
Interventions
AK112 + paclitaxel, Paclitaxel ± ramucirumab
Enrollment
110 participants
Primary completion
Apr 2028
Study completion
Dec 2028
First posted
Apr 2025
Last updated
Jun 2025

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov