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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour.
This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with advanced oesophageal squamous cell carcinoma (ESCC),to evaluate the efficacy and safety of LBL-024 combination therapy.
This study will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 combination therapy.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled, and the randomized, open, positive control trial design will be adopted.Subjects who meet the criteria will be randomly assigned to the experimental group and the control group in a ratio of 2: 1.
This trial will enroll up to 110 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatin | Experimental | LBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatin. Capecitabine is orally administered and other drugs are Intravenous infusion. |
|
| Tislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatin | Active Comparator | Tislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatin. Capecitabine is orally administered and other drugs are Intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-024 for Injection | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | Percentage of participants achieving CR and PR and stable disease (SD). | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Duration of Response(DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen | Contact | 010-88121122 | doctorshenlin@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Cisplatin Injection | Drug | Intravenous infusion |
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| Paclitaxel Injection | Drug | Intravenous infusion |
|
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| Tislelizumab Injection | Drug | Intravenous infusion |
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| 5-Fluorouracil injection | Drug | Intravenous infusion |
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| Capecitabine tablets | Drug | Oral administration |
|
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The period from the participants first achieving CR or PR to disease progression. |
| From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Cmax | Maximum serum concentration | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Tmax | After taking a single dose, Time to reach maximum plasma concentration | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| immunogenicity | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) |
| AnYang Tumor Hospital | Not yet recruiting | Anyang | Henan | 455000 | China |
|
| The First Affiliated Hospital of Henan University of Science & Technology | Recruiting | Luoyang | Henan | 471003 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 451191 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Suining Central Hospital | Recruiting | Suining | Sichuan | 629099 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| C000707970 | tislelizumab |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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