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This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 cohort 1 | Experimental | Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. |
|
| Part 1 cohort 2 | Experimental | Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. |
|
| Part 2 cohort 1 | Experimental | Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. |
|
| Part 2 cohort 2 | Experimental | Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab | Drug | IV infusion,Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance | Up to approximately 2 years | |
| Pathological complete response (pCR) rates | pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response(MPR) rates | MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes | Up to approximately 2 years |
| Tumor regression grade(TRG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weifeng Song, MD | Contact | +86(0760)89873999 | clinicaltrials@akesobio.com | |
| Han Liang, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Provincial Tumor Hospital | Recruiting | Tianjin | China |
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| AK117 | Drug | IV infusion,Specified dose on specified days |
|
| Oxaliplatin | Drug | IV infusion,Specified dose on specified days |
|
| Tegafur-gimeracil-oteracil potassium | Drug | Oral,Specified dose on specified days |
|
| Docetaxel | Drug | IV infusion,Specified dose on specified days |
|
| 5-Fluorouracil | Drug | IV infusion,Specified dose on specified days |
|
| Up to approximately 2 years |
| R0 resection rate | Up to approximately 2 years |
| Tumor descending stage rate | Proportion of subjects whose tumor TNM stage decreased from baseline before surgery | Up to approximately 2 years |
| ORR | Up to approximately 2 years |
| EFS | Up to approximately 2 years |
| OS | Up to approximately 2 years |
| PK | Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points | Up to approximately 2 years |
| ADA | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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