Siewert Type II Adenocarcinoma of the Esophagogastric JunctionPhase 2NCT07607210
A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction
A Phase 2 study testing SHR-1701+SOX in people with Siewert Type II Adenocarcinoma of the Esophagogastric Junction, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Siewert Type II Adenocarcinoma of the Esophagogastric Junction
- What is being tested?
- SHR-1701+SOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -)； 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria)； 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
- routine blood tests:
- HB≥90g/L；
- ANC≥1.5×109/L；
- PLT≥100×109/L；
- biochemical examination:
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- ALT and AST<2.5ULN（liver metastasis: ALT and AST<5ULN）；
- TBIL≤1.5ULN；
- Creatinine ≤1.5ULN； 9.Left ventricular ejection fraction is >50%； 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.
Who cannot join
- Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
- Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
- Cardia or pyloric obstruction;
- Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
- Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
- Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
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- Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency);
- History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;
- Pregnant or breastfeeding women;
- Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this study.
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
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Ziqiang Tian, +8618531118000, tizq12@vip.163.com
About this study
Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.
- Being tested
- SHR-1701+SOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701+SOXDrug
SHR-1701: 1800mg, iv, d1, q3w； SOX: S-1：40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin：130 mg/m2 IV D1；
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701+SOX | Experimental | SHR-1701: 1800mg, iv, d1, q3w； SOX: S-1：40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin：130 mg/m2 IV D1； Receives: Drug: SHR-1701+SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological Complete Response(pCR)
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
Measured: 1-year
R0 resection rate
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
Measured: 1-year
Secondary outcomes (3)
Major Pathological Response(MPR)
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
Measured: 1-year
PFS(Progression-Free Survival)
The time from the start of treatment until tumor progression or death from any cause.
Measured: 3 years
OS(Overall Survival )
Time from enrollment to death from any cause. For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Siewert Type II Adenocarcinoma of the Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziqiang Tian, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607210
- Sponsor's protocol ID
- AZL-EJC
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 May 2026
- Results posted
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT07607210
- Acronym / sponsor ID
- AZL-EJC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 May 2026 (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.
Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701+SOX | Experimental | Drug: SHR-1701+SOXSHR-1701: 1800mg, iv, d1, q3w； SOX: S-1：40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin：130 mg/m2 IV D1； |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -)； 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria)； 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
- routine blood tests:
- biochemical examination:
Key exclusion criteria (13 listed)
- Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
- Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
- Cardia or pyloric obstruction;
- Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
- Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
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 |
|---|---|---|
| SHR-1701+SOXSHR-1701: 1800mg, iv, d1, q3w； SOX: S-1：40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin：130 mg/m2 IV D1； | Drug | SHR-1701+SOX |
Primary outcome
pathological Complete Response(pCR)
Time frame: 1-year
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
R0 resection rate
Time frame: 1-year
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
3 secondary outcomes
Major Pathological Response(MPR)
Time frame: 1-year
PFS(Progression-Free Survival)
Time frame: 3 years
OS(Overall Survival )
Time frame: 3 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 26 May 2026.
- 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.
Ziqiang Tian principal investigator
Hebei Medical University Fourth Hospital
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 SHR-1701+SOX in people with Siewert Type II Adenocarcinoma of the Esophagogastric Junction, run by Hebei Medical University Fourth Hospital 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 9 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: opening soon, as of the sponsor's last update on 26 May 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 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 Ziqiang Tian (18531118000, tizq12@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological Complete Response(pCR) (time frame: 1-year). The study lists 2 primary outcomes in all. 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 26 May 2026.