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First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma

Primary Purpose

Gastrointestinal Neuroendocrine Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Durvalumab and Chemotherapy(oxaliplatin and capecitabine)
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neuroendocrine Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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. Exclusion Criteria: 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.; 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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination therapy as first-line treatment

Arm Description

Durvalumab combined with XELOX chemotherapy as the first-line treatment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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);
Progression-free Survival
from the time of enrollment to the time of progression or death from any cause;
Overall survival time
from the time of enrollment to the time of death;
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

Full Information

First Posted
August 26, 2023
Last Updated
October 1, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06070740
Brief Title
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma
Official Title
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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]
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neuroendocrine Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy as first-line treatment
Arm Type
Experimental
Arm Description
Durvalumab combined with XELOX chemotherapy as the first-line treatment
Intervention Type
Drug
Intervention Name(s)
Durvalumab and Chemotherapy(oxaliplatin and capecitabine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The proportion of patients who achieved complete remission or partial remission due to tumor size reduction (according to RECIST 1.1 standard)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Disease Control Rate
Description
The proportion of patients whose tumor shrinks and achieve complete remission, partial remission or stable condition (according to RECIST 1.1 standard);
Time Frame
through study completion, an average of 1 year
Title
Progression-free Survival
Description
from the time of enrollment to the time of progression or death from any cause;
Time Frame
through study completion, an average of 1 year
Title
Overall survival time
Description
from the time of enrollment to the time of death;
Time Frame
through study completion, an average of 1 year
Title
Adverse events
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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.; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuejuan Cheng, MD
Phone
13911234636
Email
chengyuejuanpumch@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuejuan Cheng
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuejuan Cheng
Phone
13911234636

12. IPD Sharing Statement

Learn more about this trial

First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma

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