Leptomeningeal MetastasisPhase 2NCT05385185
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
A Phase 2 study testing Camrelizumab or envafolimab in people with Leptomeningeal Metastasis and Immune Checkpoint Inhibitor, run by Hebei Medical University at 1 site in China.
Trial summary
immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis, Immune Checkpoint Inhibitor, Endostatin
- What is being tested?
- Camrelizumab or envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 3 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥18 years old, gender unlimited;
- A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
- A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
- Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
- Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
- Signed the informed consent and was willing to follow the experimental protocol and follow-up
Who cannot join
- Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
- Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
- Be allergic to PD-1 inhibitor and recombinant human endostatin
- The female patient planned to be pregnant, was pregnant and lactating -
Trial locations and contacts
1 site in 1 country.
jiao xue qi, master contact
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Hebei Medical University
Hebei
hui bu, phD, 13831106903, buhuimy1@163.com
About this study
immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe
Read the detailed description
We will recruit 20 patients with leptomeningeal metastases from lung cancer.
- Being tested
- Camrelizumab or envafolimab
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab or envafolimabDrug
Also called Recombinant human vascular endostatin
combine Camrelizumab or envafolimab with Recombinant human vascular endostatin
| Study group | Role | What they receive |
|---|---|---|
| Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin | Experimental | Camrelizumab 200mg intravenously, once every 21 days or envafolimab 150mg subcutaneous injection,once a week Endostatin 30mg/d was administered intravenously for 7 days (d1-d7). The interval between Endostatin and next was 2 weeks. Receives: Drug: Camrelizumab or envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month overall survival rate
The 3-month survival rate after treatment
Measured: 3 month
safty
Adverse events related to treatment
Measured: 2 years
Secondary outcomes (3)
iPFS
Intracranial progression-free survival
Measured: 2 years
extracranial PFS
extracranial progression-free survival
Measured: 2 years
DCR
disease control rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 May 2022
- Primary completion3 May 2024 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Bu, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385185
- Sponsor's protocol ID
- BH006
- Status last verified
- May 2022
- First submitted
- 7 Jul 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the patients information should be protected
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
- ClinicalTrials.gov ID
- NCT05385185
- Acronym / sponsor ID
- BH006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 3 May 2024 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 23 May 2022 (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.
immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe
Detailed description
We will recruit 20 patients with leptomeningeal metastases from lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin | Experimental | Drug: Camrelizumab or envafolimabCamrelizumab 200mg intravenously, once every 21 days or envafolimab 150mg subcutaneous injection,once a week Endostatin 30mg/d was administered intravenously for 7 days (d1-d7). The interval between Endostatin and next was 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old, gender unlimited;
- A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
- A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
- Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
- Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
Key exclusion criteria (4 listed)
- Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
- Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
- Be allergic to PD-1 inhibitor and recombinant human endostatin
- The female patient planned to be pregnant, was pregnant and lactating -
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 |
|---|---|---|
| Camrelizumab or envafolimabAlso: Recombinant human vascular endostatincombine Camrelizumab or envafolimab with Recombinant human vascular endostatin | Drug | Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin |
Primary outcome
3-month overall survival rate
Time frame: 3 month
The 3-month survival rate after treatment
safty
Time frame: 2 years
Adverse events related to treatment
3 secondary outcomes
iPFS
Time frame: 2 years
extracranial PFS
Time frame: 2 years
DCR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No. the patients information should be protected
Related trials for Leptomeningeal Metastasis
RecruitingPhase 1/2
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Leptomeningeal Metastasis
Active, not recruitingObservational study
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Lung Adenocarcinoma EGFR-mutated, Leptomeningeal Metastasis From Lung Cancer
Recruiting
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
RecruitingPhase 1/2
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Breast Cancer
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. This study is not recruiting at the moment.
jiao xue qi, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab or envafolimab in people with Leptomeningeal Metastasis and Immune Checkpoint Inhibitor, run by Hebei Medical University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hui bu, PhD (0311-66003711-211, buhuimy1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month overall survival rate (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.