Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Ad… (NCT05853172) | Clinical Trial Compass
UnknownPhase 2
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
China30 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
✓. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.
✓. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma
✓. At least one measurable tumor lesion per RECIST v1.1;
✓. Major organ functions are adequate;
✓. Expected survival is ≥ 3 months;
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;
Exclusion criteria
✕. Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;
✕. 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;
✕. Central nervous system, lung, or bone metastases;
✕. Known history of active or autoimmune disease;
✕. Known history of other malignancies;
✕. Known history of severe cardiovascular and cerebrovascular diseases;
What they're measuring
1
R0 surgical conversion rate
Timeframe: up to 2 years
Trial details
NCT IDNCT05853172
SponsorTianjin Medical University Cancer Institute and Hospital