New drug combo aims to boost surgery success for esophageal cancer
NCT ID NCT07607210
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding an experimental immunotherapy drug (SHR-1701) to standard chemotherapy can improve outcomes for people with a specific type of esophageal cancer (Siewert type II) that can be surgically removed. About 38 participants will receive the drug combination before and after surgery. The main goal is to see if the cancer is completely gone at the time of surgery (pathological complete response) and if the tumor can be fully removed (R0 resection).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1701 (an experimental immunotherapy drug) combined with chemotherapy (S-1 and oxaliplatin)
- What this could lead to
- If successful, this could offer a more effective treatment approach for this specific esophageal cancer, potentially increasing the chance of complete tumor removal during surgery.
- What could go wrong
- This is a small, early-phase trial (38 participants) with no results yet. The drug combination may cause significant side effects, and the benefit over standard treatment is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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: 1. routine blood tests: 1. HB≥90g/L; 2. ANC≥1.5×109/L; 3. PLT≥100×109/L; 2. biochemical examination: 1. ALT and AST\<2.5ULN(liver metastasis: ALT and AST\<5ULN); 2. TBIL≤1.5ULN; 3. 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. Exclusion Criteria: 1. Known signs of active bleeding from the lesion (except for a positive fecal occult blood test); 2. Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction; 3. Cardia or pyloric obstruction; 4. 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; 5. 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); 6. 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; 7. Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period; 8. 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); 9. History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose; 10. Congenital or acquired immunodeficiency (e.g., HIV infection); 11. 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; 12. Pregnant or breastfeeding women; 13. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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Other studies related to the condition(s) this trial covers.