Subjects With Resectable and Localized Gastric CancerPhase 2NeoChanceNCT04196465
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers
A Phase 2 study testing IMC-001 in people with Subjects With Resectable and Localized Gastric Cancer and Subjects With Resectable Esophageal Cancer or Liver Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer, Subjects With Resectable Liver Cancer
- What is being tested?
- IMC-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2019to 26 Sep 2028
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <Disease-related inclusion criteria>
- Histologically confirmed localized gastric adenocarcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma or clinically diagnosed hepatocellular carcinoma according to American Association for the Study of Liver Disease (AASLD) guidelines.However, in cases of hepatic carcinoma that can be clinically diagnosed according to AASLD guideline, no biopsy is performed.
- Curatively resectable gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma
- Gastric adenocarcinoma: clinical stage ≥T2 or regional lymph node metastasis (N+) (AJCC 8th)
- Esophageal squamous cell carcinoma: clinical stage ≥T1b or N+ (AJCC 8th)
- Hepatocellular carcinoma: a single hepatocellular carcinoma limited to liver or 3 or less hepatocellular carcinoma limited to liver without invasion to main portal trunk
Show all 21Show fewer
- The requirements for hematology, blood chemistry, and functionality in major organs are as follows (should be met within 7 days prior to the first administration of investigational medicinal product):
- Absolute neutrophil count ≥1,000/μL
- Platelets count ≥75,000/μL
- Total bilirubin ≤1.5 × Upper limit of Normal (ULN) (subjects with Gilbert syndrome: bilirubin ≤ 3.0 × ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/minute (creatinine clearance is first calculated by the formula of Cockcroft-Gault and in case of the value less than 50 mL/min, by collecting and examining 24-hour urine the subjects with the creatine clearance ≥50 mL/minute can be enrolled) (Refer to Supplement 1).
- Urine protein-creatinine ratio (UPC) ≤1 (in case of UPC >1, by collecting and examining 24-hour urine the subjects with the urine protein <2 g/day can be enrolled)
- Also, in case of hepatocellular carcinoma, liver function with Child-Pugh grade A (Refer to Supplement 2) and encephalopathy grade 0.
- Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Refer to Supplement 3).
- Tumor tissue specimen, classified as appropriate for biomarker analysis, must be provided (in case of hepatocellular carcinoma, subjects, without tissue specimen prior to the administration of investigational medicinal product, are allowed for enrollment into the study).
- <General inclusion criteria>
- Aged ≥ 19 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Signed informed consent form
- In the case of fertility men and women, Those who should be using adequate contraceptive measures while on study drug and for 3months following the last dose of study drug.
Who cannot join
- <Tumor-related exclusion criteria>
- Curatively unresectable or metastatic disease
- Any prior treatment for gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma. However, in case of hepatocellular carcinoma, it is possible for subjects to be enrolled into the study only if the treatment for local lesion was carried out ≥6 months ago and the treated area showed disease progression, or a curatively resectable new lesion has occurred outside the previously treated area, and other inclusion/exclusion criteria are met.
- Patients with history of other cancers within three years prior to the study treatment. However, patients with other cancers with less influence on their prognosis such as carcinoma in situ or thyroid papillary carcinoma, in the opinion of the investigator, can be enrolled into the study.
- History of hepatic encephalopathy.
- Clinically significant ascites defined as follows:
Show all 24Show fewer
- When screening, the physical examination reveals ascites or
- Previous ascites that required treatment and continuous prevention or current ascites that require treatment.
- <Investigational medicinal product-related exclusion criteria>
- History of active autoimmune disease with systematic treatment (i.e. immunomodulator, corticosteroid, or immunosuppressant) required within the past 2 years. Replacement therapy (e.g. physiological corticosteroid replacement therapy due to dysfunction of thyroxine, insulin, adrenal gland, or pituitary gland, etc.) is not regarded as a form of systematic treatment and would be allowed.
- Diagnosis of immunodeficiency or within 7 days prior to the first administration of investigational medicinal product treatments with chronic systematic steroids (the dose equivalent to 10 mg/day of prednisone) or immunosuppressive therapy in any other forms are not permitted.
- History of non-infectious interstitial pneumonia requiring treatment of steroids or currently diagnosed.
- Any prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or other antibodies or drugs, specifically target co-stimulatory T cells or immune checkpoint pathways.
- <General exclusion criteria>
- Any known hypersensitivity or anaphylaxis of severeness to recombinant proteins containing monoclonal antibodies.
- Active infection with systematic treatment required.
- From the viewpoint of the investigator, medical conditions, treatments, or laboratory test abnormalities that are likely to cause confusion in clinical trial results, or that are likely to interfere with subjects' participation throughout the entire study, or that are not considered to be in the best interests of the subjects.
- Positive urine test or blood pregnancy test in childbearing females within 7 days prior to the first administration of investigational medicinal product.
- Pregnant or lactating, or during the scheduled study period of 90 days after the final administration of investigational medicinal product, subjects have a plan to have conception.
- Diagnosis of symptomatic congestive heart failure (i.e. New York Heart Association Classification class II and up) or history of clinically significant heart arrhythmia that requires other antiarrhythmic drugs other than beta blockers and digoxin, or currently diagnosed or occurrence of conduction disorders (atrial fibrillation, paroxysmal supraventricular tachycardia are exceptional) within 6 months prior to the study, active coronary artery diseases, unstable angina, new occurrence of angina within 3 months before enrollment of the study, cardiac infarction within 6 months before enrollment of the study.
- History of human immunodeficiency virus (HIV 1/2 antibody)
- Subjects with active hepatitis B (HBsAg-positive or detectable HBV DNA) or hepatitis C (detectable HCV RNA). Patients with hepatitis B can be enrolled in the study, only if HBV DNA <500 IU/mL (or 2500 copies/mL). Patients with positive-HCV antibody can be enrolled only if negative HCV RNA.
- History of allogeneic tissue/solid organ transplant.
- Inoculation with live vaccine 28 days prior to the first administration of investigational medicinal product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers(Neo-Chance Study)
This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.
Read the detailed description
This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.
The sample size of the study is determined based on a major pathologic response rate (primary endpoint) and by using Simon's single stage design from the subjects who receive preoperative neoadjuvant therapy of IMC-001.
In each cancer cohort group, the null and alternative response rates are assumed as 5% and 20%, respectively. This provides a power of 80% when calculating the difference between major pathologic response rates of 5% and 20% in two-tailed significance level of 0.153 (Type I error[two-tailed] of 15.3%). In order to reject the null hypothesis, at least two major pathological respondents are needed among 14 assessable subjects for each cancer cohort. After choosing the margin of safety as 10%, each cancer cohort will require 16 subjects and therefore a total of 48 subjects will be enrolled into the study.
- Conditions
- Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer, Subjects With Resectable Liver Cancer
- Being tested
- IMC-001
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-001Drug
IMC-001 is a fully human anti-programmed cell death ligand 1 (PD-L1) recombinant monoclonal antibody that strongly binds to PD-L1 to inhibit its binding to programmed cell death protein 1 (PD-1) or B7-1 (CD80). IMC-001 showed robust dose-dependent efficacy in animal models and no evidence of toxicity in cynomolgus monkeys
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant IMC-001 | Experimental | Neoadjuvant immune check point inhibitor of IMC-001 in participants with resectable and localized gastric cancer, esophageal cancer, and hepatocellular carcinoma Receives: Drug: IMC-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response rate
Evaluation of major pathologic response rate (a proportion of residual viable tumor cells <10%) after administration of pre-operative immune checkpoint inhibitor IMC-001
Measured: After surgical resection within 28days
Secondary outcomes (9)
The safety and feasibility
Evaluation of safety assessed by NCI CTCAE v. 4.03 and evaluation of feasibility assessed by the occurrence of delays in prearranged surgery.
Measured: Within 14 days after the end of Cycle 2 (+,- 4days)
R0 resection rate
Evaluation of R0 resection rate
Measured: After surgical resection within 1 month
Clinical tumor response rate
Evaluation of clinical tumor response rate by RECIST v1.1
Measured: 1 month
Clnical disease control rate
Evaluation of clinical disease control rate by RECIST v1.1
Measured: 1 month
Progression-free survival
Evaluation of progression-free survival
Measured: 2 years
Relapse-free survival
Evaluation of relapse-free survival
Measured: 2 years
Overall survival
Evaluation of overall survival
Measured: 2 years
The rates and patterns of cancer progression/relapse
Evaluation of the rates of cancer progression/relapse
Measured: 2 years
Patterns of cancer progression/relapse
Evaluation of the pattern of cancer progression/relapse
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start9 Sep 2019
- Primary completion9 Sep 2028 (estimated)
- Study completion26 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjects With Resectable and Localized Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Model description
- This study is a prospective, IMC-001 single arm, open label, single center, phase II study.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sook Ryun Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196465
- Sponsor's protocol ID
- 2019-0988
- Acronym
- NeoChance
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2019
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bang YH, Kang D, Lee S, Kim S, Jeon I, Park E, Choi J, Song GW, Yoo MW, Song JS, Song IH, Kim YH, Kim HR, Song HJ, Kim DH, Choi KD, Lee JH, Ahn JY, Shim JH, Lee D, Choi J, Kim JE, Kim SY, Bae DJ, Park SR. Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study. NPJ Precis Oncol. 2026 Jul 3. doi: 10.1038/s41698-026-01571-2. Online ahead of print.
PubMed 42399382
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers(Neo-Chance Study)
- ClinicalTrials.gov ID
- NCT04196465
- Acronym / sponsor ID
- NeoChance / 2019-0988
- Conditions
- Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer, Subjects With Resectable Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 9 Sep 2028 (estimated)
- Study completion
- 26 Sep 2028 (estimated)
- First posted
- 12 Dec 2019 (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 is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.
Detailed description
This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.
The sample size of the study is determined based on a major pathologic response rate (primary endpoint) and by using Simon's single stage design from the subjects who receive preoperative neoadjuvant therapy of IMC-001.
In each cancer cohort group, the null and alternative response rates are assumed as 5% and 20%, respectively. This provides a power of 80% when calculating the difference between major pathologic response rates of 5% and 20% in two-tailed significance level of 0.153 (Type I error[two-tailed] of 15.3%). In order to reject the null hypothesis, at least two major pathological respondents are needed among 14 assessable subjects for each cancer cohort. After choosing the margin of safety as 10%, each cancer cohort will require 16 subjects and therefore a total of 48 subjects will be enrolled into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, IMC-001 single arm, open label, single center, phase II study.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant IMC-001 | Experimental | Drug: IMC-001Neoadjuvant immune check point inhibitor of IMC-001 in participants with resectable and localized gastric cancer, esophageal cancer, and hepatocellular carcinoma |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- <Disease-related inclusion criteria>
- Histologically confirmed localized gastric adenocarcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma or clinically diagnosed hepatocellular carcinoma according to American Association for the Study of Liver Disease (AASLD) guidelines.However, in cases of hepatic carcinoma that can be clinically diagnosed according to AASLD guideline, no biopsy is performed.
- Curatively resectable gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma
- The requirements for hematology, blood chemistry, and functionality in major organs are as follows (should be met within 7 days prior to the first administration of investigational medicinal product):
- Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Refer to Supplement 3).
Key exclusion criteria (24 listed)
- <Tumor-related exclusion criteria>
- Curatively unresectable or metastatic disease
- Any prior treatment for gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma. However, in case of hepatocellular carcinoma, it is possible for subjects to be enrolled into the study only if the treatment for local lesion was carried out ≥6 months ago and the treated area showed disease progression, or a curatively resectable new lesion has occurred outside the previously treated area, and other inclusion/exclusion criteria are met.
- Patients with history of other cancers within three years prior to the study treatment. However, patients with other cancers with less influence on their prognosis such as carcinoma in situ or thyroid papillary carcinoma, in the opinion of the investigator, can be enrolled into the study.
- History of hepatic encephalopathy.
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 |
|---|---|---|
| IMC-001IMC-001 is a fully human anti-programmed cell death ligand 1 (PD-L1) recombinant monoclonal antibody that strongly binds to PD-L1 to inhibit its binding to programmed cell death protein 1 (PD-1) or B7-1 (CD80). IMC-001 showed robust dose-dependent efficacy in animal models and no evidence of toxicity in cynomolgus monkeys | Drug | Neoadjuvant IMC-001 |
Primary outcome
Major pathologic response rate
Time frame: After surgical resection within 28days
Evaluation of major pathologic response rate (a proportion of residual viable tumor cells <10%) after administration of pre-operative immune checkpoint inhibitor IMC-001
9 secondary outcomes
The safety and feasibility
Time frame: Within 14 days after the end of Cycle 2 (+,- 4days)
R0 resection rate
Time frame: After surgical resection within 1 month
Clinical tumor response rate
Time frame: 1 month
Clnical disease control rate
Time frame: 1 month
Progression-free survival
Time frame: 2 years
Relapse-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
The rates and patterns of cancer progression/relapse
Time frame: 2 years
Patterns of cancer progression/relapse
Time frame: 2 years
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 29 Oct 2026.
- Derived from this study: PubMed 42399382Bang YH, Kang D, Lee S, Kim S, Jeon I, Park E, Choi J, Song GW, Yoo MW, Song JS, Song IH, Kim YH, Kim HR, Song HJ, Kim DH, Choi KD, Lee JH, Ahn JY, Shim JH, Lee D, Choi J, Kim JE, Kim SY, Bae DJ, Park SR. Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study. NPJ Precis Oncol. 2026 Jul 3. doi: 10.1038/s41698-026-01571-2. Online ahead of print.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 IMC-001 in people with Subjects With Resectable and Localized Gastric Cancer and Subjects With Resectable Esophageal Cancer or Liver Cancer, run by Asan Medical Center 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 21 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response rate (time frame: After surgical resection within 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196465, which also lists 1 linked publication.
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 29 Oct 2026.