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Trial Title:
Clinical Study of Pabolizumab for Neoadjuvant Immunotherapy of Locally Advanced Microsatellite-unstable Gastric Adenocarcinoma
NCT ID:
NCT05816863
Condition:
Gastric Cancer
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
PD-1
immuno-oncology
pabolizumab
neoadjuvant
immunotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
pabolizumab
Description:
pabolizumab IV every 3 weeks (q3w)
Arm group label:
Experimental
Summary:
Our study is aim to evaluate the efficacy and safety of pabolizumab in neoadjuvant
immunotherapy of locally advanced microsatellite-unstable gastric adenocarcinoma.
Detailed description:
Patients with microsatellite-unstable gastric adenocarcinoma cannot benefit from
chemotherapy, According to the guideline of the Chinese Society of Clinical Oncology, It
is not recommended to receive chemotherapy for patients with microsatellite-unstable
gastric cancer, therefore, immunotherapy is the only hope for those patients.
Criteria for eligibility:
Study pop:
Patients with locally advanced microsatellite-unstable gastric adenocarcinoma
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. ECOG 0-1.
2. Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and
biopsy pathology confirmed adenocarcinoma of the stomach.
3. Advanced gastric cancer as assessed by ultrasonography and/or gastric CT (cT3-T4b,
Nany, M0).
4. Biopsy tissues with IHC indicates deficient mismatch repair(dMMR),that is, the loss
of at least one of the four proteins ,MSH1, MSH2, MSH6, PMS2; or gene detection
implies MSI-H;
5. Subjects must have at least one measurable lesion in accordance with RECIST v1.1. A
lesion previously treated with local therapies such as radiotherapy can be
considered a target lesion if there is objective evidence of progression in the
lesion.
6. Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
7. Has life expectancy of greater than 6 months.
8. Adequate organ function.
Exclusion Criteria:
1. Female participants who are pregnant or breastfeeding or expecting to conceive
children within the projected duration of the study, starting with the screening
visit through180 days after the last dose of chemotherapy or through 120 days after
the last dose of pembrolizumab, whichever is greater.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage.
3. as a known additional malignancy that is progressing or has required active
treatment within the past 5 years. Note: Participants with basal cell carcinoma of
the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have
undergone potentially curative therapy are not excluded.
4. Any disease requiring systemic treatment. Local replacement steroids are permitted
5. Subjects with active, known or suspected autoimmune disease, or a medical history of
autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave
disease, psoriasis or eczema not requiring systemic treatment within the last 2
years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses
of hormone replacement therapy and type I diabetes only requiring steady doses of
insulin replacement therapy, or completely relieved childhood asthma that requires
no intervention in adulthood, or primary diseases that will not relapse unless
triggered by external factors.
6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation.
7. Known history of active tuberculosis (TB).
8. Serious infections within 4 weeks prior to the first dose of study drug, including
but not limited to complications requiring hospitalization, sepsis or severe
pneumonia.
9. An active infection requiring systemic therapy.
10. Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA
exceeding 2000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects
with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <500 IU/ mL)
, and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are
eligible only if the HCV RNA test results are negative.
11. Known history of testing positive for human immunodeficiency virus (HIV).
12. Any conditions that, in the investigator's opinion, may put subjects treated with
the study drug at risks, or interfere with the evaluation of study drug or subject
safety, or the interpretation of results.
13. Known history of allergy or hypersensitivity to Pabolizumab or any of its components
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiafu Ji, MD
Phone:
0086-01-88196391
Email:
jiafuj@hotmail.com
Contact backup:
Last name:
Jialin Li, MD
Phone:
0086-01-88196967
Email:
ljldoc@163.com
Investigator:
Last name:
Zhaode Bu, MD
Email:
Principal Investigator
Investigator:
Last name:
Jialin Li, MD
Email:
Sub-Investigator
Start date:
March 1, 2023
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816863
