Gastrointestinal Neuroendocrine CarcinomaPhase 2NCT06070740
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma
A Phase 2 study testing Durvalumab and Chemotherapy(oxaliplatin and capecitabine) in people with Gastrointestinal Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study [NCT ID not yet assigned] Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neuroendocrine Carcinoma
- What is being tested?
- Durvalumab and Chemotherapy(oxaliplatin and capecitabine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytopathologically confirmed as gastrointestinal NEC, or MiNEN (the neuroendocrine part is NEC).
- Have not previously received systemic treatment for the unresectable locally advanced or metastatic gastrointestinal NEC. Note: For patients who have previously received neoadjuvant/adjuvant or radical chemotherapy/chemoradiotherapy, the time from the end of the previous treatment to the first diagnosis of disease progression/relapse should not be less than 6 months.
- Patients with ECOG physical status score 0-1;
- The following baseline requirments must be met within 7 days before enrollment:
- blood tests i. Neutrophil count ≥1.5×10^9/L. ii. Hemoglobin count (HGB) ≥ 90 g/L. iii. Platelet count (PLT) ≥ 80×10^9/L.
- Liver and kidney function) i. Creatinine clearance ≥30ml/min.ii. Total bilirubin ≤ 1.5 ULN (Patients with biliary obstruction are allowed to be enrolled if received biliary drainage or stent implantation, and total bilirubin ≤ 2.5 × ULN).iii. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5xULN, for patients with liver metastases: ≤ 5xULN iv. Serum albumin ≥ 2.7 g/dL
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- Able to provide written informed consent, and able to understand and agree to abide by the research requirements and evaluation;
- Measurable lesions according to RECIST 1.1 criteria;
- Female patients must be surgically sterilized women, postmenopausal or take high-efficiency contraception during the treatment and within 12 weeks after the treatment; male patients must be surgically sterilized men, or take high-efficiency contraception during the treatment and within 6 months after the treatment.
Who cannot join
- History of other malignant tumors in the past 5 years or at the time of enrollment (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- History of treatment with durvalumab or other PD-1/PD-L1 inhibitors; known allergies to macromolecular protein biologics, or to any ingredients of durvalumab;
- In active or history of autoimmune or inflammatory diseases (including inflammatory bowel disease, systemic lupus erythematosus, Sarcoidosis syndrome, granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveal inflammation, etc.);
- Received the following treatment within 2 weeks before enrollment or still in use: immunosuppressants, systemic or absorbable local hormone therapy to achieve immunosuppression (dose> 10mg/day prednisone or other equivalent steroids)
- History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks before the start of treatment;
- History with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, etc.;
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- In active infection, including tuberculosis (evaluated by clinical assessment, including clinical history, physical examination, imaging findings, and tuberculosis examination according to the clinical practice), hepatitis B (known positive for hepatitis B virus [HBV] surface antigen [HbsAg]), Hepatitis C (HCV) or human immunodeficiency virus (human immunodeficiency virus (HIV) 1/2 antibody positive) and history of or cured HBV (defined as the presence of hepatitis B core IgG antibody and the absence of HBsAg);
- Received anti-tumor monoclonal antibody (mAb) within 4 weeks before the first use of the trialed medication, or adverse events caused by the previousl treatment have not recovered (recovery defined as ≤ grade 1 or reached the baseline level). Note: ≤2 grade neuropathy and ≤2 grade alopecia are not included. If the subject has undergone major surgery, the toxicity and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
- Received live vaccines within 4 weeks before starting the treatment or may receive live vaccines during the study;
- Known history of psychotropic substance abuse, alcoholism or drug abuse;
- The subject is unable or does not agree to take the cost of self-paid examination and treatment;
- The researcher believes that it should be excluded from this study, for example, according to the researcher's evaluation, the subject has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) that require combined treatment, serious abnormal laboratory results, family or social factors, which would affect the safety of the subjects or the collection of data and samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Yuejuan Cheng, 13911234636
About this study
Official title: First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study
First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study [NCT ID not yet assigned]
Read the detailed description
A prospective Single-arm Phase II Study to evaluate the effectiveness and safety of the combination treatment of durvalumab with XELOX chemotherapy as the first-line in advanced gastrointestinal neuroendocrine carcinoma
- Being tested
- Durvalumab and Chemotherapy(oxaliplatin and capecitabine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab and Chemotherapy(oxaliplatin and capecitabine)Drug
Combination therapy includes:
Durvalumab: intravenous infusion with a fixed dose of 1500 mg on day 1, repeated every 3 weeks ± 3 days; Chemotherapy: Oxaliplatin 130mg/m2 intravenous infusion on day 1, capecitabine 1000mg/m2, orally, twice a day, from day 1 to day 14; repeated every 3 weeks ± 3 days;
After 6 cycles of combination therapy, maintain with durvalumab 1500 mg every 4 weeks ± 3 days for 2 years. Terminate the trial if confirmed disease progression, initiation of other anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent or other reasons considered by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy as first-line treatment | Experimental | Durvalumab combined with XELOX chemotherapy as the first-line treatment Receives: Drug: Durvalumab and Chemotherapy(oxaliplatin and capecitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients who achieved complete remission or partial remission due to tumor size reduction (according to RECIST 1.1 standard)
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Disease Control Rate
The proportion of patients whose tumor shrinks and achieve complete remission, partial remission or stable condition (according to RECIST 1.1 standard);
Measured: through study completion, an average of 1 year
Progression-free Survival
from the time of enrollment to the time of progression or death from any cause;
Measured: through study completion, an average of 1 year
Overall survival time
from the time of enrollment to the time of death;
Measured: through study completion, an average of 1 year
Adverse events
the frequency and severity of all adverse events (Adverse Event, AE), the severity of adverse events is evaluated according to the CTC AE v5.0 standard
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YueJuan Cheng, Peking Union Medical College Hospital
- Investigators
- Yuejuan Cheng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070740
- Sponsor's protocol ID
- K3631
- Status last verified
- Oct 2023
- First submitted
- 26 Aug 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study
- ClinicalTrials.gov ID
- NCT06070740
- Acronym / sponsor ID
- K3631
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2023 (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.
First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study [NCT ID not yet assigned]
Detailed description
A prospective Single-arm Phase II Study to evaluate the effectiveness and safety of the combination treatment of durvalumab with XELOX chemotherapy as the first-line in advanced gastrointestinal neuroendocrine carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy as first-line treatment | Experimental | Drug: Durvalumab and Chemotherapy(oxaliplatin and capecitabine)Durvalumab combined with XELOX chemotherapy as the first-line treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytopathologically confirmed as gastrointestinal NEC, or MiNEN (the neuroendocrine part is NEC).
- Have not previously received systemic treatment for the unresectable locally advanced or metastatic gastrointestinal NEC. Note: For patients who have previously received neoadjuvant/adjuvant or radical chemotherapy/chemoradiotherapy, the time from the end of the previous treatment to the first diagnosis of disease progression/relapse should not be less than 6 months.
- Patients with ECOG physical status score 0-1;
- The following baseline requirments must be met within 7 days before enrollment:
- Able to provide written informed consent, and able to understand and agree to abide by the research requirements and evaluation;
Key exclusion criteria (12 listed)
- History of other malignant tumors in the past 5 years or at the time of enrollment (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- History of treatment with durvalumab or other PD-1/PD-L1 inhibitors; known allergies to macromolecular protein biologics, or to any ingredients of durvalumab;
- In active or history of autoimmune or inflammatory diseases (including inflammatory bowel disease, systemic lupus erythematosus, Sarcoidosis syndrome, granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveal inflammation, etc.);
- Received the following treatment within 2 weeks before enrollment or still in use: immunosuppressants, systemic or absorbable local hormone therapy to achieve immunosuppression (dose> 10mg/day prednisone or other equivalent steroids)
- History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks before the start of treatment;
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 |
|---|---|---|
| Durvalumab and Chemotherapy(oxaliplatin and capecitabine)Combination therapy includes: Durvalumab: intravenous infusion with a fixed dose of 1500 mg on day 1, repeated every 3 weeks ± 3 days; Chemotherapy: Oxaliplatin 130mg/m2 intravenous infusion on day 1, capecitabine 1000mg/m2, orally, twice a day, from day 1 to day 14; repeated every 3 weeks ± 3 days; After 6 cycles of combination therapy, maintain with durvalumab 1500 mg every 4 weeks ± 3 days for 2 years. Terminate the trial if confirmed disease progression, initiation of other anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent or other reasons considered by the investigators. | Drug | Combination therapy as first-line treatment |
Primary outcome
Objective Response Rate
Time frame: through study completion, an average of 1 year
The proportion of patients who achieved complete remission or partial remission due to tumor size reduction (according to RECIST 1.1 standard)
4 secondary outcomes
Disease Control Rate
Time frame: through study completion, an average of 1 year
Progression-free Survival
Time frame: through study completion, an average of 1 year
Overall survival time
Time frame: through study completion, an average of 1 year
Adverse events
Time frame: through study completion, an average of 1 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 6 Oct 2023.
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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.
Yuejuan Cheng principal investigator
Peking Union Medical College Hospital
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 Durvalumab and Chemotherapy(oxaliplatin and capecitabine) in people with Gastrointestinal Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Oct 2023. 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?
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 Yuejuan Cheng, MD (13911234636, chengyuejuanpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: through study completion, an average of 1 year). 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 6 Oct 2023.