Clinical TrialID 8203
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
NCT06157827
Advanced Neuroendocrine Carcinoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8203
- Evidence Id
- 8203
- Core Evidence Id
- 8203
- Source Clinical Trial Id
- 8201
- Herb2 Clinical Trial Id
- HBCT008201
- Nct Id
- NCT06157827
- Title
- A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
- Status
- Recruiting
- Phase
- Phase 1|Phase 2
- Study Result
- No
- Study Condition
- Advanced Neuroendocrine Carcinoma
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: LBL-024 for Injection|DRUG: Etoposide Injection|DRUG: Cisplatin for Injection|DRUG: Carboplatin Injection
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 138
- Outcome Measure
- Objective Response Rate (ORR), ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II ., From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).|Dose-limiting toxicities（DLT）, DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib., Within 3 weeks after receiving the first dose of the test drug (DLT assessment for subjects in dose escalation phase).|Maximum tolerated dose (MTD), MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase Ib ., Within 3 weeks after receiving the first dose of the test drug (MTD assessment for subjects in dose escalation phase).
- Sponsor Collaborator
- Nanjing Leads Biolabs Co.,Ltd
- Funded By
- INDUSTRY
- Location
- Anhui Provincial Hospital, Hefei, Anhui, 230001, China|Anhui Cancer Hospital, Hefei, Anhui, 230031, China|Beijing GoBroad Hospital, Beijing, Beijing, 100070, China|Beijing Cancer Hospital, Beijing, Beijing, 100142, China|Chongqing University Cancer Hospital, Chongqing, Chongqing, 400030, China|Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China|The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, 510080, China|Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530021, China|Harbin Medical University Cancer Hospital, Ha'erbin, Heilongjiang, 150081, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, China|Henan Cancer Hospital, Zhengzhou, Henan, 450008, China|Hubei Cancer Hospital, Wuhan, Hubei, 430079, China|Xiangyang Central Hospital, Xiangyang, Hubei, 441000, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Liaoning Cancer Hospital, Shenyang, Liaoning, 110801, China|Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China|Shandong Cancer Hospital, Jinan, Shandong, 250117, China|Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China|Shanxi Cancer hospital, Taiyuan, Shanxi, 030013, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610044, China|The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China|The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China|Sir Run Run Shaw Hospital，Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China|Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China
- Other Id
- LBL-024-CN002
- Start Date
- 2023-12-08
- Primary Completion Date
- 2026-11-20
- Completion Date
- 2027-07-20
- First Posted
- 2023-12-06
- Results First Posted
- Last Update Posted
- 2024-09-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06157827
- Title Cn
- Title En
- A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
- Bilingual Status
- semi_complete