Gastric CancerNCT05816863
Clinical Study of Pabolizumab for Neoadjuvant Immunotherapy of Locally Advanced Microsatellite-unstable Gastric Adenocarcinoma
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Our study is aim to evaluate the efficacy and safety of pabolizumab in neoadjuvant immunotherapy of locally advanced microsatellite-unstable gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma
- What is being tested?
- pabolizumab
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced microsatellite-unstable gastric adenocarcinoma
Who may be able to join
- ECOG 0-1.
- Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and biopsy pathology confirmed adenocarcinoma of the stomach.
- Advanced gastric cancer as assessed by ultrasonography and/or gastric CT (cT3-T4b, Nany, M0).
- 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;
- 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.
- Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
- Has life expectancy of greater than 6 months.
- Adequate organ function.
Who cannot join
- 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.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 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.
- Any disease requiring systemic treatment. Local replacement steroids are permitted
- 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.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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- Known history of active tuberculosis (TB).
- 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.
- An active infection requiring systemic therapy.
- 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.
- Known history of testing positive for human immunodeficiency virus (HIV).
- 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.
- Known history of allergy or hypersensitivity to Pabolizumab or any of its components
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jiafu Ji, MD, 0086-01-88196391, jiafuj@hotmail.com
Jialin Li, MD, 0086-01-88196967, ljldoc@163.com
About this study
Our study is aim to evaluate the efficacy and safety of pabolizumab in neoadjuvant immunotherapy of locally advanced microsatellite-unstable gastric adenocarcinoma.
Read the 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.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Being tested
- pabolizumab
- Keywords
- PD-1, immuno-oncology, pabolizumab, neoadjuvant, immunotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pabolizumabDrug
pabolizumab IV every 3 weeks (q3w)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | pabolizumab Receives: Drug: pabolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue
Measured: Up to approximately 15 Weeks (Time of surgery)
Secondary outcomes (3)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 71 months.
Progression free survival (PFS)
The time from registration to the date of disease progression or death resulting from any cause.
Measured: 3 years.
R0 resection rate
Proportion of patients who achieved R0 resection.
Measured: Within 4 weeks following the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaode Bu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816863
- Sponsor's protocol ID
- LGH2021374
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Pabolizumab for Neoadjuvant Immunotherapy of Locally Advanced Microsatellite-unstable Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05816863
- Acronym / sponsor ID
- LGH2021374
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- PD-1, immuno-oncology, pabolizumab, neoadjuvant, immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 18 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: pabolizumabpabolizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced microsatellite-unstable gastric adenocarcinoma
Key inclusion criteria (8 listed)
- ECOG 0-1.
- Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and biopsy pathology confirmed adenocarcinoma of the stomach.
- Advanced gastric cancer as assessed by ultrasonography and/or gastric CT (cT3-T4b, Nany, M0).
- 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;
- 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.
Key exclusion criteria (13 listed)
- 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.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 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.
- Any disease requiring systemic treatment. Local replacement steroids are permitted
- 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.
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 |
|---|---|---|
| pabolizumabpabolizumab IV every 3 weeks (q3w) | Drug | Experimental |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: Up to approximately 15 Weeks (Time of surgery)
pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 71 months.
Progression free survival (PFS)
Time frame: 3 years.
R0 resection rate
Time frame: Within 4 weeks following the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Peking University Cancer Hospital & Institute 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 8 inclusion and 13 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 18 Apr 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.
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 Jialin Li, MD (8601088196970, ljldoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: Up to approximately 15 Weeks (Time of surgery)). 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 18 Apr 2023.