Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
Study Details
Study Description
Brief Summary
This is a prospective, single-arm, open-label,single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AK104 plus apatinib, paclitaxel and S-1 AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles. |
Drug: AK104
Subjects will receive AK104 until disease progression or for up to 6 cycles.
Drug: Apatinib
Subjects will receive apatinib until disease progression or for up to 6 cycles.
Drug: Paclitaxel
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
Drug: S-1
Subjects will receive S-1 until disease progression or for up to 6 cycles.
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Outcome Measures
Primary Outcome Measures
- R0 surgical conversion rate [up to 2 years]
Secondary Outcome Measures
- R0 resection rate [up to 2 years]
- Pathological complete response (pCR) [up to 2 years]
- Pathological major response (MPR) [up to 2 years]
- Objective response rate (ORR) [up to 2 years]
- Disease control rate (DCR) [up to 2 years]
- Progression-free survival (PFS) [up to 2 years]
- Adverse event (AE) [up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
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Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.
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Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma
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At least one measurable tumor lesion per RECIST v1.1;
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Major organ functions are adequate;
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Expected survival is ≥ 3 months;
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Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;
Exclusion Criteria:
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Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;
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Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors;
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Central nervous system, lung, or bone metastases;
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Known history of active or autoimmune disease;
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Known history of other malignancies;
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Known history of severe cardiovascular and cerebrovascular diseases;
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Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;
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Active infection or fever of unknown origin;
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Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;
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Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;
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Known history of mental disorder or psychoactive substance abuse;
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Hypersensitivity to the drugs of this regimen;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
- Principal Investigator: Han Liang, MD, Tianjin Medical University Cancer Institute and Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E20221047