Esophagogastric Junction AdenocarcinomaPhase 2NCT05170503
Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma
A Phase 2 study testing Sintilimab in people with Esophagogastric Junction Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagogastric Junction Adenocarcinoma
- What is being tested?
- Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2021to 1 Jan 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aN0 or T1-4aN1-3M0
- No previous anti-tumor treatment
- ECOG PS: 0-1
- The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period)：Absolute neutrophil count ≥ 1.5 × 109/L； Platelet ≥ 90 × 109/L； Hemoglobin ≥ 9g / dl; Serum albumin ≥ 3G / dl; Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, the levels of T3 and T4 should be investigated at the same time. If the levels of T3 and T4 are normal, they can be included in the group); Bilirubin ≤ ULN; ALT and AST ≤ 1.5 times ULN; AKP ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min.
- Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug.
- The patients voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Who cannot join
- Known Her-2 positive
- Any active autoimmune disease or history of autoimmunity (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma in which subjects need bronchodilators for medical intervention cannot be included).
- Severe allergic reaction to monoclonal antibody.
- The number of neutrophils in peripheral blood was less than 1500 / mm3.
- There are cardiac clinical symptoms or diseases that are not well controlled.
- Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy.
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- The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive, HBVDNA > 2000IU/ml or copy number > 104/ml; Hepatitis C reference: HCV antibody positive.
- According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
- The researchers judged the patients with high risk of esophageal perforation or no potential possibility of surgery through endoscopic ultrasonography or imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hong Yang, Ph.D.,M.D., 008613560405144, yanghong@sysucc.org.cn
Jiyang Chen, 008618826238208, chenjy1@sysucc.org.cn
About this study
Official title: Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma.
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Being tested
- Sintilimab
- Keywords
- Esophagogastric Junction Adenocarcinoma, neoadjuvant, chemo-immunotherapy, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200mg iv drip. Qd D1 + Oxaliplatin 130/m2 iv drip. Qd D1 + Tegafur (Gimeracil and Oteracil Potassium Capsules) [40mg/m2 if BSA <1.25m2, 50mg/m2 if BSA ≥1.25m2 \& <1.5m2, 60mg/m2 if BSA ≥1.5m2] po. Bid D1-14 for three cycles
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) Combined With Chemotherapy (Tegafur+Oxaliplatin) Each patient will complete 3 cycles of neoadjuvant therapy. After evaluating the radiographical response, operation with curative extent (Ivor-lewis or Mckeown procedure with two-field lymph node dissection) will be performed after 6 to 8 weeks from the last cycle of neoadjuvant treatment. Patients with and without surgery enter the survival follow-up period. Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Measured: From date of enrollment until one month after resection
Secondary outcomes (3)
Overall survival
The time from randomization to death from any cause.
Measured: 2-5 years
Disease-Free-Survival
The time between the beginning of treatment and the observation of disease progression or death from any cause.
Measured: 2-5 years
R0 resection rate
The percentage of patients who undergo complete resection
Measured: From date of enrollment until one month after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start29 Dec 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170503
- Sponsor's protocol ID
- SYSUCC B2021-356-01
- Status last verified
- Jun 2025
- First submitted
- 24 Dec 2021
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon reaseonable request with a plan
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT05170503
- Acronym / sponsor ID
- SYSUCC B2021-356-01
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Keywords
- Esophagogastric Junction Adenocarcinoma, neoadjuvant, chemo-immunotherapy, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 28 Dec 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.
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Drug: SintilimabNeoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) Combined With Chemotherapy (Tegafur+Oxaliplatin) Each patient will complete 3 cycles of neoadjuvant therapy. After evaluating the radiographical response, operation with curative extent (Ivor-lewis or Mckeown procedure with two-field lymph node dissection) will be performed after 6 to 8 weeks from the last cycle of neoadjuvant treatment. Patients with and without surgery enter the survival follow-up period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aN0 or T1-4aN1-3M0
- No previous anti-tumor treatment
- ECOG PS: 0-1
- The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period)：Absolute neutrophil count ≥ 1.5 × 109/L； Platelet ≥ 90 × 109/L； Hemoglobin ≥ 9g / dl; Serum albumin ≥ 3G / dl; Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, the levels of T3 and T4 should be investigated at the same time. If the levels of T3 and T4 are normal, they can be included in the group); Bilirubin ≤ ULN; ALT and AST ≤ 1.5 times ULN; AKP ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min.
- Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug.
Key exclusion criteria (9 listed)
- Known Her-2 positive
- Any active autoimmune disease or history of autoimmunity (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma in which subjects need bronchodilators for medical intervention cannot be included).
- Severe allergic reaction to monoclonal antibody.
- The number of neutrophils in peripheral blood was less than 1500 / mm3.
- There are cardiac clinical symptoms or diseases that are not well controlled.
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 |
|---|---|---|
| SintilimabSintilimab 200mg iv drip. Qd D1 + Oxaliplatin 130/m2 iv drip. Qd D1 + Tegafur (Gimeracil and Oteracil Potassium Capsules) [40mg/m2 if BSA <1.25m2, 50mg/m2 if BSA ≥1.25m2 \& <1.5m2, 60mg/m2 if BSA ≥1.5m2] po. Bid D1-14 for three cycles | Drug | Neoadjuvant chemo-immunotherapy |
Primary outcome
Pathologic Complete Response
Time frame: From date of enrollment until one month after resection
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
3 secondary outcomes
Overall survival
Time frame: 2-5 years
Disease-Free-Survival
Time frame: 2-5 years
R0 resection rate
Time frame: From date of enrollment until one month after resection
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 12 Jun 2025.
- Individual participant dataSharing planned: No. upon reaseonable request with a plan
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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.
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 Sintilimab in people with Esophagogastric Junction Adenocarcinoma, run by Sun Yat-sen University 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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.
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?
Contact Hong Yang, M.D. Ph.D. (+8613560405144 ext. +8613560405144, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (time frame: From date of enrollment until one month after resection). 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 12 Jun 2025.