Clinical trial · Interventional
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
NCT05853172CI-TRIAL-00066320unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| Apatinib | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104 plus apatinib, paclitaxel and S-1
- description
- 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.
- interventionNames
- Drug: AK104
- Drug: Apatinib
- Drug: Paclitaxel
- Drug: S-1
Primary outcomes (1)
- measure
- R0 surgical conversion rate
- timeFrame
- up to 2 years
Secondary outcomes (7)
- measure
- R0 resection rate
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.