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The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite instability (MSI), DNA mismatch repair (MMR), tumor mutation load (TMB), lymphocyte subgroup and cytokines.
Gastric cancer is a common malignant tumor of digestive tract.The incidence of gastric cancer in China accounts for about half of the world's total, the incidence rate ranks second, and the mortality rate ranks second.Moreover, the proportion of early gastric cancer in China is very low, only about 20%. Most of them are in advanced stage at the time of discovery. The overall 5-year survival rate is less than 15%, which seriously threatens the health and life of Chinese people.For nearly 90% of HER2 negative patients with advanced gastric and gastroesophageal junction adenocarcinoma (g / GEJ), the current first-line treatment option is chemotherapy, and the efficacy of available drugs is very limited.The ORR of the first-line chemotherapy is about 40%, and the OS is about 10 months. New therapeutic drugs are urgently needed to improve the efficacy of advanced G/GEJ.The purpose of this study was to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab+albumin-bound paclitaxel+S-1 | Experimental | camrelizumab+albumin-bound paclitaxel+S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab, Albumin-bound paclitaxel, S-1 | Other | Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the proportion of patients with a documented complete response, and partial response (CR+PR). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DcR) | defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD). | up to 2 years |
| Overall survival (OS) | Defined as the date from random grouping to death from any cause. |
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Inclusion Criteria:
Age 18-75 years old, no gender limit.
ECOG 0-1; estimated survival time ≥12 weeks.
Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
At least one measurable lesion (RECIST1.1 standard).
Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment> 6 months.
For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time> 2 weeks.
The main organs and bone marrow function are basically normal:
Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Tumor Hospital | Recruiting | Luoyang | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41550955 | Derived | Wu C, Li S, Hou X. Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Front Immunol. 2026 Jan 2;16:1634502. doi: 10.3389/fimmu.2025.1634502. eCollection 2025. |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000068196 | Albumin-Bound Paclitaxel |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| up to 2 years |
| Progression free survival (PFS) | Defined as the time betwween the onset of treatment and the observation of disease progression or death from any cause. | up to 2 years |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |