Advanced Extrapulmonary Neuroendocrine CarcinomaPhase 3NCT07720193

A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC

A Phase 3 study testing LBL-024 for Injection, Etoposide injection and Cisplatin injection in people with Advanced Extrapulmonary Neuroendocrine Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 36 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This trial is a randomized, double-blind, placebo-controlled multicenter phase III clinical study aiming to evaluate the efficacy and safety of LBL-024 compared with placebo in combination with etoposide and cisplatin or carboplatin (EP or EC) for the first-line treatment of advanced EP-NEC patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Extrapulmonary Neuroendocrine Carcinoma
What is being tested?: LBL-024 for Injection, Etoposide injection and Cisplatin injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 280 participants
Where: 36 sitesChina
Study dates: 16 Nov 2026to 22 Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent.
Age ≥ 18 years (inclusive) at the time of signing informed consent.
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
expected survival time of at least 12 weeks.
According to RECIST 1.1, participants were required to have at least one measurable lesion.
Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.

Who cannot join

Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial.
Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
serious cardiac and cerebrovascular disorder.
History of immunodeficiency including HIV antibody test positive.

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patients with active hepatitis B or C.
Women during pregnancy or lactation.
The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Shen contact

010-88121122

doctorshenlin@sina.cn

City, postcode or hospital

36 sites in 1 country

China36 sites

AnYang Tumor Hospital
Anyang, Henan, 455000
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100070
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
The First Hospital of Jilin University
Changchun, Jilin, 130021
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Hunan Cancer Hospital
Changsha, Hunan, 410013
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510062
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Shandong Cancer Hospital
Jinan, Shandong, 250117
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, 110167
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30012
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361102
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453100
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Henan Cancer Hospital
Zhengzhou, Henan, 450003
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment of Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Read the detailed description

A total of 280 patients with advanced EP-NEC without systemic treatment will be enrolled in this study. Eligible patients will be randomly assigned to the experimental group or control group at a ratio of 1:1.

Conditions: Advanced Extrapulmonary Neuroendocrine Carcinoma
Being tested: LBL-024 for Injection, Etoposide injection, Cisplatin injection, Carboplatin injection, LBL-024 placebo for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LBL-024 for InjectionDrug
Also called LBL-024
Intravenous infusion
Etoposide injectionDrug
Also called Etoposide
Intravenous infusion
Cisplatin injectionDrug
Also called Cisplatin
Intravenous infusion
Carboplatin injectionDrug
Also called Carboplatin
Intravenous infusion
LBL-024 placebo for injectionDrug
Also called LBL-024 placebo
Intravenous infusion

Study groups in NCT07720193
Study group	Role	What they receive
LBL-024 + Etoposide + Cisplatin/carboplatin	Experimental	LBL-024 + Etoposide + Cisplatin/carboplatin. Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Etoposide injection; Drug: Cisplatin injection; Drug: Carboplatin injection
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin	Active comparator	LBL-024 placebo+ Etoposide + Cisplatin/carbopla. Intravenous infusion. Receives: Drug: Etoposide injection; Drug: Cisplatin injection; Drug: Carboplatin injection; Drug: LBL-024 placebo for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival (OS)
Time from randomization to death for any reason in a clinical trial.
Measured: 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)

Secondary outcomes (8)

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.
Measured: 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)
Disease Control Rate(DCR）
Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.
Measured: 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）
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 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)
Progression-free Survival(PFS)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance .
Measured: 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)
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of combination therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE).
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Maximum drug concentration in plasma after administration.
Measured: 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 administration,Time to reach maximum drug concentration in plasma.
Measured: 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.Immunogenicity refers to the performance that can elicit an immune response.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202622 Dec 2030

First posted22 Jul 2026
Study start16 Nov 2026 (estimated)
Primary completion22 Dec 2030 (estimated)
Study completion22 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Extrapulmonary Neuroendocrine CarcinomaStudies of the same condition, open and under way.
More trials run by Nanjing Leads Biolabs Co.,LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 280 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07720193
Sponsor's protocol ID: LBL-024-CN301
Status last verified: Oct 2026
First submitted: 17 Jul 2026
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Lin Shen

010-88121122

doctorshenlin@sina.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2/3
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
RecruitingPhase 3
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
Extrapulmonary Neuroendocrine Cancer (epNEC)
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
Not yet recruitingPhase 3
QLC5508 vs. Investigator's Choice Chemotherapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
Extrapulmonary Neuroendocrine Carcinoma

All Advanced Extrapulmonary Neuroendocrine Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment of Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
ClinicalTrials.gov ID: NCT07720193
Acronym / sponsor ID: LBL-024-CN301
Conditions: Advanced Extrapulmonary Neuroendocrine Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 280 participants (estimated)
Lead sponsor: Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
Collaborators: Peking University Cancer Hospital & Institute
Study start: 16 Nov 2026 (estimated)
Primary completion: 22 Dec 2030 (estimated)
Study completion: 22 Dec 2030 (estimated)
First posted: 22 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LBL-024 + Etoposide + Cisplatin/carboplatin	Experimental	Drug: LBL-024 for Injection, Drug: Etoposide injection, Drug: Cisplatin injection, Drug: Carboplatin injectionLBL-024 + Etoposide + Cisplatin/carboplatin. Intravenous infusion.
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin	Active comparator	Drug: Etoposide injection, Drug: Cisplatin injection, Drug: Carboplatin injection, Drug: LBL-024 placebo for injectionLBL-024 placebo+ Etoposide + Cisplatin/carbopla. Intravenous infusion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent.
Age ≥ 18 years (inclusive) at the time of signing informed consent.
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
expected survival time of at least 12 weeks.
According to RECIST 1.1, participants were required to have at least one measurable lesion.

Key exclusion criteria (9 listed)

Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial.
Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
serious cardiac and cerebrovascular disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LBL-024 for InjectionAlso: LBL-024Intravenous infusion	Drug	LBL-024 + Etoposide + Cisplatin/carboplatin
Etoposide injectionAlso: EtoposideIntravenous infusion	Drug	LBL-024 + Etoposide + Cisplatin/carboplatin, LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
Cisplatin injectionAlso: CisplatinIntravenous infusion	Drug	LBL-024 + Etoposide + Cisplatin/carboplatin, LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
Carboplatin injectionAlso: CarboplatinIntravenous infusion	Drug	LBL-024 + Etoposide + Cisplatin/carboplatin, LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
LBL-024 placebo for injectionAlso: LBL-024 placeboIntravenous infusion	Drug	LBL-024 placebo+ Etoposide + Cisplatin/carboplatin

Primary outcome

Overall survival (OS)
Time frame: 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)
Time from randomization to death for any reason in a clinical trial.

8 secondary outcomes

Objective Response Rate (ORR)
Time frame: 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)
Disease Control Rate(DCR）
Time frame: 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）
Time frame: 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)
Progression-free Survival(PFS)
Time frame: 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)
Occurrence of adverse event (AE) and serious adverse event (SAE)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Time frame: 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
Time frame: 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
Time frame: 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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Extrapulmonary Neuroendocrine Carcinoma

RecruitingPhase 2/3
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
RecruitingPhase 3
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
Extrapulmonary Neuroendocrine Cancer (epNEC)
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
Not yet recruitingPhase 3
QLC5508 vs. Investigator's Choice Chemotherapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
Extrapulmonary Neuroendocrine Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Lin Shen contact

010-88121122

doctorshenlin@sina.cn

Lin Shen principal investigator

Peking University Cancer Hospital & Institute

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin Shen (010-88121122, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.