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The aim population is histopathologically confirmed locally unresectable advanced recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and teggio (SOX) in first-line treatment of unreactable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.
Every 21 days is a cycle, and treatment is scheduled for 6 cycles. Chemotherapy drugs until disease progression, toxicity intolerance, the start of new anti - tumor treatment, withdrawal, loss of access or death, etc., already reached first, shall be the basis for termination.
Treatment was effective for more than 6 treatment cycles and toxicity was, the subjects were judged by the researchers when to terminate the treatment and adjust the follow-up treatment plan.
For disease progression, toxicity intolerance, and initiation of new antitumor therapies.
For subjects who donot reach terminal events such as treatment, withdrawal, loss of follow-up or death, at the end of chemotherapy , the follow-up maintenance regimen was adjusted according to the researchers' evaluation.
The screening period of the study was 14 days. The screening test was completed and the evaluation was completed.
Subjects with standard discharge entered the treatment period, and the frequency of administration was determined according to the protocol.
Conduct treatment and complete relevant tests and assessments before each administration.
Tumor imaging was assessed every 6 weeks (±7 days) and all subjects were treated.
At the end of the visit, safety and imaging evaluations should be completed. Complete follow-up was conducted for a total of 90 days. Continue to receive tumor evaluation and imaging at a frequency of 2-3 months. Evaluation until disease progression, new antitumor therapy, withdrawal, Lost or dead, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab combine CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules | Drug | Toripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of patients whose tumors shrink to a certain extent and remain there for a certain period of time, including CR+PR cases | All subjects receive tumor assessment every 6 weeks until desease progress, up to 24mons. Objective response rate is defined as the date from ICF signation to the date of first documented progression or date of death from any cause, whichever came first. |
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Inclusion Criteria:
1) blood routine examination: absolute neutrophil count (ANC) ≥1.5×109/L; platelet count (PLT) ≥85×109/L; hemoglobin (HGB) 90 g/L or higher; 2) liver function: total bilirubin (TBIL) ≤2× normal upper limit (ULN) was required in patients without liver metastasis; alanine aminotransferase (ALT) and amino transferase (AST) ≤2.5×ULN.Requirements for patients with liver metastasis: serum total bilirubin (TBIL) ≤2× normal upper limit (ULN); alanine ammonia ALT and AST were ≤5×ULN; 3) renal function: creatinine clearance rate (Ccr) ≥60mL/min; 4) full coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; 6. According to RECIST v1.1, there is at least one measurable lesion or evaluable lesion; 7. Previous (new) adjuvant chemotherapy/adjuvant radiotherapy ending time to disease recurrence time >6 months; 8. Expected survival time ≥12 weeks; 9. Female subjects of child-bearing age or male subjects whose sexual partners are female of child-bearing age shall take effective contraception throughout the treatment period and 6 months after the treatment period measures; 10. Subjects voluntarily participate in the study, sign the informed consent, and comply with the protocol visit and related procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuying Xiao, doc | Contact | 13564579313 | xiaoxiuying2002@163.com |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| C104201 | gimeracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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