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To assess the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. Based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450 Injection + Anlotinib Hydrochloride Capsules | Experimental | TQB2450 injection: 1200 mg/time, intravenous drip, day 1, Q3W; Anlotinib Hydrochloride Capsules: 8 mg/dose, once daily (QD), continuously used for 2 weeks, stopped for 1 week, and taken orally before breakfast (the starting dose of Anlotinib Hydrochloride is 8 mg, and it is allowed to be increased to 10 mg after two cycles of use) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 Injection + Anlotinib Hydrochloride Capsules | Drug | Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Incidence and severity of adverse events | Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first) |
| serious adverse event | Incidence and Severity of Serious Adverse Events | Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR:According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment. | Up to approximately 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin ming Yu, postdoctor | Contact | 13806406293 | sdyujinming@126.com | |
| Xiang jiao Meng, doctor | Contact | 13793150996 | mengxiangjiao@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40114144 | Derived | Liu X, Yin X, Zhuang L, Wen J, Wei Z, Cui W, Yu M, Zhao K, Liu L, Kong L, Jiang L, Jing X, Zhu H, Wang X, Dong X, Yu J, Meng X. Efficacy and safety of TQB2450 combined with anlotinib as maintenance therapy for LS-SCLC after definitive concurrent or sequential chemoradiotherapy: a prospective phase Ib study. BMC Cancer. 2025 Mar 20;25(1):509. doi: 10.1186/s12885-025-13885-8. |
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| disease control rate | The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases | Up to approximately 36 months |
| duration of remission | The time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause | Up to approximately 36 months |