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NCT Number: NCT05170503

Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Sintilimab

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall survival

    Time frame: 2-5 years

    The time from randomization to death from any cause.

  2. Disease-Free-Survival

    Time frame: 2-5 years

    The time between the beginning of treatment and the observation of disease progression or death from any cause.

  3. R0 resection rate

    Time frame: From date of enrollment until one month after resection

    The percentage of patients who undergo complete resection

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Yang, M.D. Ph.D.

CONTACT

[email protected]

+8613560405144 ext. +8613560405144

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Dec 28, 2021
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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