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The goal of this clinical trial is to learn if treatment modality including albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative treatment for hepatoid adenocarcinoma of stomach | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response rate | The proportion of subjects with node-negative lymph nodes and without residual viable tumor cells in the total number of subjects | within 10 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| major pathological response rate | The proportion of subjects with surviving tumor cells ≤10% in total subjects; Time Frame: within 10 days after surgery | Within 10 days after surgery |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anqiang Wang, MD | Contact | 861088196970 | wanganqiang0902@163.com | |
| Jialin Li, MD | Contact | 861088196970 | ljldoc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | China |
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perioperative treatment with albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules and sintilimab
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Masking Description
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|
Proportion of patients who achieved pre-defined tumor volume reduction , including patients with complete response (CR) and partial response (PR).
| From enrollment to surgery, assessed up to 3 months |
| Event-free survival | From the start of treatment to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause | From date of enrollment until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 3 years |
| Disease free survival | It usually starts from the time when the patient receives treatment (such as surgery), and ends at the time when the disease recurs (such as tumor recurrence, metastasis) or when the patient dies for any reason | From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 3 years |
| overall survival | It refers to the period from when the patient is diagnosed until death due to any cause. | From date of diagnosis until the date of death from any cause, assessed up to 3 years |
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| C104201 | gimeracil |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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