Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

• Status: Recruiting
• Trial end date: 2025-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Apatinib; Paclitaxel

Criteria

Inclusion Criteria:

1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.

2. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.

3. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma

4. At least one measurable tumor lesion per RECIST v1.1;

5. Major organ functions are adequate;

6. Expected survival is ≥ 3 months;

7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;

Exclusion Criteria:

1. Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;

2. 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;

3. Central nervous system, lung, or bone metastases;

4. Known history of active or autoimmune disease;

5. Known history of other malignancies;

6. Known history of severe cardiovascular and cerebrovascular diseases;

7. Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;

8. Active infection or fever of unknown origin;

9. Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;

10. Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;

11. Known history of mental disorder or psychoactive substance abuse;

12. Hypersensitivity to the drugs of this regimen;