Neuroendocrine TumorsPhase 2NCT06764368
Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors
A Phase 2 study testing Adebrelimab + Apatinib in people with Neuroendocrine Tumors, run by Beijing Chest Hospital.
Trial summary
This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Adebrelimab + Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jun 2028
- Phase
- Phase 2
- 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
- Age ≥ 18 years, no gender restriction;
- Pathologically confirmed unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, and carcinoid tumors). For carcinoid tumors, patients must be atypical carcinoid cases deemed by the investigator to require systemic treatment due to tumor-related symptoms or continuous tumor growth.
- No prior systemic anti-tumor treatment;
- Expected survival of at least 3 months;
- ECOG performance status: 0-2;
- At least one evaluable lesion based on imaging, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), with at least one measurable tumor lesion (non-lymph node lesion with a maximum diameter ≥ 10 mm or lymph node lesion with a short diameter ≥ 15 mm at baseline);
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- Patients with brain metastases must either be asymptomatic or have stable brain metastases to be eligible;
- Normal function of major organs;
- Women of childbearing potential must have used reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result. Both male and female patients of childbearing potential must agree to use adequate contraception during the study and for 6 months after treatment;
- Subjects must voluntarily participate in the study, sign informed consent, demonstrate good compliance, and agree to follow-up.
Who cannot join
- Subjects with extensive leptomeningeal metastases or active brain metastases with significant symptoms;
- Spinal cord compression not definitively treated with surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without clinical evidence of stabilization for at least 1 week prior to randomization;
- Uncontrolled or symptomatic hypercalcemia;
- Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors;
- Use of immunosuppressive drugs within 14 days prior to the first dose of Adebrelimab;
- Active tuberculosis (TB) within 48 weeks before screening or a history of active TB infection, regardless of prior treatment;
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- Vaccination with live attenuated or preventive vaccines within 4 weeks before the first dose or planned vaccination during the study;
- History of allogeneic bone marrow transplantation or solid organ transplantation;
- Severe cardiovascular disease;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Any active autoimmune disease or a history of autoimmune disease;
- Coagulation abnormalities (INR > 1.5 or prothrombin time [PT] > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency, or current thrombolytic or anticoagulation therapy;
- Major surgery, traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment, or planned major surgery during the study;
- Severe infections such as sepsis or septic shock within 14 days before enrollment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia;
- Significant hemoptysis within 2 months prior to enrollment, defined as more than half a teaspoon (2.5 ml) of blood daily, or any significant clinical bleeding or bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, baseline fecal occult blood ++ or higher, or vasculitis;
- HBsAg positive with levels exceeding the upper limit of normal (1000 copies/ml or 500 IU/ml); patients with past or cured HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg, with normal HBV DNA during screening) may be included; HCV antibody positive with HCV viral load exceeding the upper limit of normal/HCV RNA or HCV Ab indicating acute or chronic infection; known HIV positive status or acquired immunodeficiency syndrome (AIDS);
- Patients with a known history of allergies or suspected allergies to the study drug or any components of the study;
- Participation in another interventional clinical trial or use of any investigational product within 4 weeks prior to signing the informed consent form (ICF);
- History of substance abuse or inability to quit, or mental disorders;
- History of or concurrent malignancies requiring active treatment within the past 5 years;
- Other conditions judged by the investigator to be unsuitable for inclusion;
- Patients with asymptomatic, stable, typical/atypical carcinoid tumors are not eligible for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Single-arm, Multicenter Clinical Study of Adebrelimab Combined With Chemotherapy and Apatinib as First-line Treatment for Unresectable Locally Advanced or Metastatic Pulmonary Neuroendocrine Tumors
This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors.
This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Adebrelimab + Apatinib
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + ApatinibDrug
Induction Phase:
Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the investigator) + Apatinib (250 mg, orally, once daily) in 3-week cycles (Q3W) for 4 to 6 cycles.
Maintenance Phase:
Adebrelimab (1200 mg, Day 1) + Apatinib (250 mg, orally, once daily) will be administered for 1 year or until one of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent by the subject, voluntary withdrawal from the study, or other protocol-specified reasons.
| Study group | Role | What they receive |
|---|---|---|
| Subtype 1/2/3 | Experimental | Not described Receives: Drug: Adebrelimab + Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month PFS rate (Progression-Free Survival rate)
Measured: 12-month
Secondary outcomes (3)
Objective response rate
Measured: through study completion, an average of 2 year
Progression-free survival
Measured: through study completion, an average of 2 year
Overall survival
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongmei Zhang, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764368
- Sponsor's protocol ID
- XKZH-2024-01R
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Multicenter Clinical Study of Adebrelimab Combined With Chemotherapy and Apatinib as First-line Treatment for Unresectable Locally Advanced or Metastatic Pulmonary Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06764368
- Acronym / sponsor ID
- XKZH-2024-01R
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jan 2025 (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.
This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors.
This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subtype 1/2/3 | Experimental | Drug: Adebrelimab + Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, no gender restriction;
- Pathologically confirmed unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, and carcinoid tumors). For carcinoid tumors, patients must be atypical carcinoid cases deemed by the investigator to require systemic treatment due to tumor-related symptoms or continuous tumor growth.
- No prior systemic anti-tumor treatment;
- Expected survival of at least 3 months;
- ECOG performance status: 0-2;
Key exclusion criteria (22 listed)
- Subjects with extensive leptomeningeal metastases or active brain metastases with significant symptoms;
- Spinal cord compression not definitively treated with surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without clinical evidence of stabilization for at least 1 week prior to randomization;
- Uncontrolled or symptomatic hypercalcemia;
- Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors;
- Use of immunosuppressive drugs within 14 days prior to the first dose of Adebrelimab;
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 |
|---|---|---|
| Adebrelimab + ApatinibInduction Phase: Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the investigator) + Apatinib (250 mg, orally, once daily) in 3-week cycles (Q3W) for 4 to 6 cycles. Maintenance Phase: Adebrelimab (1200 mg, Day 1) + Apatinib (250 mg, orally, once daily) will be administered for 1 year or until one of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent by the subject, voluntary withdrawal from the study, or other protocol-specified reasons. | Drug | Subtype 1/2/3 |
Primary outcome
12-month PFS rate (Progression-Free Survival rate)
Time frame: 12-month
3 secondary outcomes
Objective response rate
Time frame: through study completion, an average of 2 year
Progression-free survival
Time frame: through study completion, an average of 2 year
Overall survival
Time frame: through study completion, an average of 2 year
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 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab + Apatinib in people with Neuroendocrine Tumors, run by Beijing Chest Hospital.
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 10 inclusion and 22 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Tongmei Zhang (+86 136 8301 6715, tongmeibj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month PFS rate (Progression-Free Survival rate) (time frame: 12-month). 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 8 Jan 2025.