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To investigate the clinical efficacy and safety of envollizumab combined with fruquintinib and SOX versus SOX in conversion therapy for patients with Her-2 negative, unresectable locally advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envolimab + fruquinitinib +SOX regimen | Experimental |
| |
| SOX regimen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envolimab | Drug | Envolizumab 300mg, D1, ih, Q3W 4-6cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical conversion rate | Defined as the proportion of patients who have undergone surgical resection after multidisciplinary assessment after completing 4-6 cycles of conversion therapy | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | Measured as the proportion of participants with a pathological complete response at the time of definitive surgery. | 4 months |
| Median disease free survival (DFS) time |
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Inclusion Criteria:
Age: 18-75 years of age;
Pathological (including histological or cytological) confirmation of gastric adenocarcinoma;
Before surgery, CT/MRI, PET-CT, if necessary, laparoscopic exploration to determine the clinical stage of T4bN0M0 and TanyN2-3M0, and determined by researchers that the local advanced patients can not be resectable;
At least one measurable detected by CT examination in accordance with the RECIST1.1
ECOG#Eastern Cooperative Oncology Group#PS#Performance Status#:0-1 scores;
The expected survival time is more than 3 months
The main organ function is normal, which should meet the following criteria:
#1#blood routine examination standards should be met#no blood transfusion within 14 days#
a.HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L #2#biochemical examination shall comply with the following criteria#
Women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test#
No other clinical studies were conducted before and during the treatment
Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
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| Fruquintinib |
| Drug |
Fruquinitinib 3mg/d, QD, PO, D1-D14, Q3W 4-6cycles |
|
| Oxaliplatin | Drug | Oxaliplatin 130 mg/m2, ivgtt 0-2h, D1, Q3W 4-6cycles |
|
| Tegafur | Drug | Tegafur was calculated according to body surface area , P.O., bid, d1-d14#And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time Q3W 4-6cycles |
|
The time from opreation to the time when only 50% of the individuals had no relapse or tumor progression
| 3 years |
| 1-year DFS rate | 1 year |
| 3-year DFS rate | 3 years |
| Objective response rate (ORR) | Defined as the percentage of the participants in the analysis population who had a confirmed patial response and complete reponse according to RECIST 1.1 based on investigator assessment | 4 months |
| Major pathological response rate (MPR) | The proportion of participants with a major pathological response (mPR) at the time of definitive surgery. | 4 months |
| R0 resection rate | Defined as no residue under the microscope after resection | 2-3 month |
| Median survival time | The time from enrollment to the time when only 50% of the individuals alive | 3 years |
| Adverse event (AEs) | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit. | 2 years |
| Quality of life (QOL) | The quality of life of patients during treatment is eveluated by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3.0) | 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |