Relapsed or Advanced Gastric AdenocarcinomaNCT05053295
Investigator-initiated Pilot Study to Investigate the Efficacy and Safety of Immuncell-LC in Combination With Nivolumab (Opdivo) in Subjects With Advanced or Recurrent Gastric Cancer
A study testing autologous activated T lymphocyte in people with Relapsed or Advanced Gastric Adenocarcinoma and Gastro-esophageal Junction Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This study was planned to evaluate the efficacy and safety of combination therapy of Immuncell-LC and nivolumab in patients with relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Relapsed or Advanced Gastric Adenocarcinoma, Gastro-esophageal Junction Cancer
- What is being tested?
- autologous activated T lymphocyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jul 2021to 30 Sep 2023
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged 19 years or above
- Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer that meets one of the following criteria:
- Confirmed relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer after at least two prior chemotherapies (Perioperative, neoadjuvant, and adjuvant chemotherapy are not considered as prior chemotherapies, but if the disease progression occurs during or within 6 months of completion of adjuvant chemotherapy, it is considered a prior chemotherapy).
- Patients who are not eligible for standard anti-cancer treatments due to contraindications, intolerance, etc. or who have no other standard treatments available for refusing the treatment may be enrolled at the judgement of the investigator regardless of the number of prior chemotherapies.
- A measurable lesion based on RECIST v1.1 (Irradiated area will be considered measurable if PD is confirmed in the area).
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
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- Life expectancy of at least 12 weeks
- Confirmed adequate hematological, hepatic, renal and coagulation functions as follows:
- Hematological function: absolute neutrophil count (ANC) ≥ 1,500/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100,000/μL B. Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN), total bilirubin ≤ 1.0 × ULN (if liver metastasis is confirmed, AST/ALT < 3 × ULN) C. Renal function: blood urine nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN D. Blood coagulation:prothrombin time (PT) (international normalized ratio, INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Fully understood the study information (purpose, procedure, etc.) and voluntarily provided a written consent to participate in this study.
Who cannot join
- 1) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products
- 2) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4
- 3) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab
- 4) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator
- 5) History of anti-cancer treatment (chemotherapy, targeted therapy [within 4 weeks for monoclonal antibody], radiation therapy, etc.) within 2 weeks prior to screening
- 6) An adverse event (AE) with prior treatments that is not resolved (CTCAE grade ≤ 1 or baseline) (with the exceptions of peripheral neuropathy or alopecia that are ≥ grade 2)
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- 7) History of immunosuppressive drugs within 2 weeks prior to screening (with the exceptions of topical, ophthalmic, intra-articular, intranasal, or inhalational corticosteroids, or systemic corticosteroids at doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid)
- 8) Administration of live vaccines, live attenuated vaccines, or inactivated vaccines within 4 weeks prior to screening
- 9) The following medical history confirmed at screening: A. Confirmed diagnosis of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) which could worsen by immunotherapy B. History of an active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, T cell lymphoma) with systemic treatment (disease controllers, corticosteroids, immunosuppressants, etc.) within 2 years prior to screening (Alternative therapies [e.g., thyroxine, insulin, physiologic replacement therapy with corticosteroids for adrenal or pituitary insufficiency] are not considered as systemic treatments) C. History of interstitial lung disease D. Concurrent infection or sepsis E. Evident myocardial failure or uncontrolled arterial hypertension F. Gastrointestinal perforation or fistula G. History of other malignant tumors excluding gastric adenocarcinoma/gastro-esophageal junction cancer within 5 years prior to screening (If the investigator determines that basal cell carcinoma/squamous cell carcinoma of the skin, localized prostate cancer, papillary thyroid carcinoma, or cervical carcinoma in situ is cured after successful treatment, the patients are eligible to participate even if 5 years have not passed)
- 10) The following concomitant diseases at screening that may affect the safety and efficacy assessments during the study at the judgement of the investigator: A. Clinically significant pericardial effusion, pleural effusion or ascites (e.g., requiring treatment) B. Clinically significant symptoms or uncontrolled central nervous system or brain metastases or carcinomatous meningitis (except if progression is not confirmed clinically and on CT/MRI for at least 4 weeks before administration of the IP and treatment with steroids, etc. is not required for 7 days before administration of the IP after treatment of central nervous system or brain metastases.) C. Diseases that may clinically increase the risk of gastrointestinal bleeding (e.g., active diverticulitis, gastro-intestinal ulcerative disease or disease that can increase the risk of perforation) D. Active hepatitis B (HbsAg positive) or C (The patients are eligible to participate in the study even if HCV antibody is positive as long as RNA is negative, as it will be considered as a prior infection) E. Severe infections or other uncontrolled active infectious diseases requiring administration of antibiotics, antivirals, etc. that may affect the safety and efficacy assessments during the study F. Thromboembolic diseases or bleeding diatheses G. Considered ineligible to participate in the study due to concomitant disease that is uncontrolled or requires treatment (e.g., heart disease, decreased lung function, decreased kidney function, hypotension, hypertension, findings of myelosuppression, hepatitis, liver cirrhosis, history of alcohol addiction, myocardial infarction)
- 11) Pregnant or breast-feeding women, or women who intend to become pregnant
- 12) Received other IP or used an investigational device within 4 weeks prior to screening
- 13) Ineligible or unable to participate in the study at the judgement of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severacen Hospital
Seoul, seoul
Jae Yong Cho, 82-2-2019-4601, CHOJY@yuhs.ac
Jae Yong Cho, CHOJY@yuhs.ac
About this study
Official title: An Open-label, Single-arm, Single-center, Investigator-initiated Pilot Study to Investigate the Efficacy and Safety of Immuncell-LC in Combination With Nivolumab (Opdivo®) in Subjects With Advanced or Recurrent Gastric Cancer
This study was planned to evaluate the efficacy and safety of combination therapy of Immuncell-LC and nivolumab in patients with relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer.
- Being tested
- autologous activated T lymphocyte
- Keywords
- Immuncell-LC, Nivolumab, ILC-IIT-09, gastric adenocarcinoma,, gastro-esophageal junction cancer
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous activated T lymphocyteDrug
Also called Immuncell-LC (Autologous activated T lymphocyte),
Drug: Immuncell-LC IV
Drug: Nivolumab (Opdivo®) IV
| Study group | Role | What they receive |
|---|---|---|
| Immuncell-LC/Nivolumab group | Experimental | Patients will receive nivolumab once a day at 4-week intervals and Immuncell-LC 12 times (3 treatments once a week, followed by 5 treatments every other week, and finally 4 treatments every 4 weeks). Receives: Drug: autologous activated T lymphocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) based on RECIST v1.1
ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months after Last Patient In)
Secondary outcomes (9)
Overall survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Measured: Until death, follow-up failure or study discontinuation (Up to approximately 12 months after Last Patient In)
Progression-free survival (PFS) based on RECIST v1.1
PFS is defined as the time from the date of enrollment day to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Duration of response (DOR) based on RECIST v1.1
DOR is defined as the time from the earliest date of qualifying response (CR or PR) until earliest date of disease progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Disease control rate (DCR) based on RECIST v1.1
DCR is defined as the percentage of participants in the analysis population who have CR (disappearance of all lesions), PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD). Responses are according to RECIST 1.1
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
ORR based on iRECIST
ORR is defined as the percentage of participants who have a best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline sum diameters). Responses are according to iRECIST
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
PFS based on iRECIST
PFS is defined as the time from the date of enrollment day to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to iRECIST
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
DOR based on iRECIST
DOR is defined as the time from the earliest date of qualifying response (CR or PR) until earliest date of disease progression or death from any cause, whichever comes first. Responses are according to iRECIST
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
DCR based on iRECIST
DCR is defined as the percentage of participants in the analysis population who have CR (disappearance of all lesions), PR (≥30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD). Responses are according to iRECIST
Measured: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Quality of life (QoL) assessment using the EORTC QLQ-STO22
EORTC STO-22 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Gastric Module (STO = stomach) (22 items), comprising five multi-item and four single-item subscales. The multi-item subscales include questions about dysphagia (4 items), dietary restriction (5 items), pain (3 items), upper gastro-esophageal symptoms such as reflux (3 items), and emotional problems such as anxiety (3 items). The single-item subscales include questions related to four gastric cancer-specific symptoms: dry mouth, body image, hair loss, and problems with taste. Items are assessed on a 4-level numerical scale with 1= "not at all", 2= "a little", 3= "quite a bit", and 4= "very much". Scores are linearly converted and summated into a scaled score from 0 to 100, with a higher score representing a worse QOL.
Measured: Until end of treatment (Up to approximately 12 months from the date the last subject was administered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start2 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Advanced Gastric AdenocarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Cho, Gangnam Severance Hospital
- Investigators
- Jae Yong Cho, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053295
- Sponsor's protocol ID
- 3-2020-0356
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Single-center, Investigator-initiated Pilot Study to Investigate the Efficacy and Safety of Immuncell-LC in Combination With Nivolumab (Opdivo®) in Subjects With Advanced or Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT05053295
- Acronym / sponsor ID
- 3-2020-0356
- Keywords
- Immuncell-LC, Nivolumab, ILC-IIT-09, gastric adenocarcinoma,, gastro-esophageal junction cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Sep 2021 (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 study was planned to evaluate the efficacy and safety of combination therapy of Immuncell-LC and nivolumab in patients with relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuncell-LC/Nivolumab group | Experimental | Drug: autologous activated T lymphocytePatients will receive nivolumab once a day at 4-week intervals and Immuncell-LC 12 times (3 treatments once a week, followed by 5 treatments every other week, and finally 4 treatments every 4 weeks). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult males and females aged 19 years or above
- Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer that meets one of the following criteria:
- A measurable lesion based on RECIST v1.1 (Irradiated area will be considered measurable if PD is confirmed in the area).
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
- Life expectancy of at least 12 weeks
Key exclusion criteria (13 listed)
- 1) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products
- 2) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4
- 3) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab
- 4) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator
- 5) History of anti-cancer treatment (chemotherapy, targeted therapy [within 4 weeks for monoclonal antibody], radiation therapy, etc.) within 2 weeks prior to screening
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 |
|---|---|---|
| autologous activated T lymphocyteAlso: Immuncell-LC (Autologous activated T lymphocyte),Drug: Immuncell-LC IV Drug: Nivolumab (Opdivo®) IV | Drug | Immuncell-LC/Nivolumab group |
Primary outcome
Objective response rate (ORR) based on RECIST v1.1
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months after Last Patient In)
ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.
9 secondary outcomes
Overall survival (OS)
Time frame: Until death, follow-up failure or study discontinuation (Up to approximately 12 months after Last Patient In)
Progression-free survival (PFS) based on RECIST v1.1
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Duration of response (DOR) based on RECIST v1.1
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Disease control rate (DCR) based on RECIST v1.1
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
ORR based on iRECIST
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
PFS based on iRECIST
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
DOR based on iRECIST
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
DCR based on iRECIST
Time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)
Quality of life (QoL) assessment using the EORTC QLQ-STO22
Time frame: Until end of treatment (Up to approximately 12 months from the date the last subject was administered)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Jae Yong Cho principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous activated T lymphocyte in people with Relapsed or Advanced Gastric Adenocarcinoma and Gastro-esophageal Junction Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 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 22 Sep 2021. 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 South Korea. 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 Jae Yong Cho (82-2-2019-4601, CHOJY@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) based on RECIST v1.1 (time frame: Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months after Last Patient In)). 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 22 Sep 2021.