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To evaluate the efficacy and safety of liposome irinotecan combined with platinum and immune checkpoint inhibitor combined with antirotinib maintenance therapy after first-line induction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposome Irinotecan | Drug | Liposome irinotecan(50mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | To evaluate the efficacy of anti-tumor | baseline up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To evaluate the efficacy of anti-tumor | baseline up to approximately 6 months |
| Disease Control Rate (DCR) | To evaluate the efficacy of anti-tumor |
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Inclusion Criteria:
Volunteer to join the study, sign the informed consent and sign the date, have good compliance, and cooperate with follow-up
Age≥18 years
Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed histologically or pathologically (according to American Veterans Lung Cancer Association, VALG staging)
ECOG 0-2
Subjects had not received any systemic treatment for ES-SCLC in the past (including chemotherapy, use of similar VEGFR inhibitors and immune checkpoint inhibitors, etc.)
Subjects with limited-stage small cell lung cancer (LS-SCLC) have received radiotherapy, chemotherapy, or chemoradiotherapy for more than 6 months
Expected survival ≥ 3 months
Must have measurable target lesions that meet RECIST1.1 criteria (CT scan length of tumor lesion >10mm); In patients with initial asymptomatic brain metastases, craniocerebral radiotherapy may be performed during induction chemotherapy
If the major organs are functioning normally, the following criteria are met:
Female who are fertile must have a serum or urine pregnancy test within 72 hours before the first medication and the result is negative. Fertile female and male subjects whose partners are fertile female must agree to a highly effective method of avoiding and breastfeeding during the study period until 90 days after the last dose of the study drug. The investigator or designee, in consultation with the subject, shall confirm that the subject understands the proper and consistent use of contraceptive methods
For males, they should be surgically sterilized or consent to a highly effective method of avoidance during the trial and for 90 days after the last administration of the experimental drug
Female participants had to agree not to breastfeed during the study period or for 180 days after the last dose of study treatment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Liu | Contact | 13898865122 | cmuliuyunpeng@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunpeng Liu | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
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| Platinum | Drug | Carboplatin (AUC 4-5) or Cisplatin (60mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle |
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| Tislelizumab | Drug | Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle |
|
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| Anlotinib | Drug | Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle |
|
| baseline up to approximately 6 months |
| overall survival (OS) | To evaluate the efficacy of anti-tumor | baseline up to approximately 12 months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | To identify the incidence of AE and SAE in clinical trial | From the initiation of the first dose to 14 days after the last dose |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010984 | Platinum |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C000707970 | tislelizumab |
| D000082082 | Immune Checkpoint Inhibitors |
| C000625192 | anlotinib |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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