Neoadjuvant immunochemotherapy for advanced esophagogastric junction cancer
Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial
This study is testing a new combination of immunotherapy and chemotherapy to see if it helps patients with advanced esophagogastric junction cancer before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Sintilimab, Immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05170503 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of combining immunotherapy with chemotherapy for patients with locally advanced esophagogastric junction adenocarcinoma. Participants will receive Sintilimab, a PD-1 inhibitor, alongside Tegafur and Oxaliplatin. The goal is to determine how well this treatment works before surgery in patients who have not received prior anti-tumor therapies. The study focuses on patients with specific tumor characteristics and organ function requirements.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed locally advanced esophagogastric junction adenocarcinoma who have not undergone previous anti-tumor treatment.
Not a fit: Patients with prior anti-tumor treatments or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with advanced esophagogastric junction adenocarcinoma.
How similar studies have performed: Other studies have shown promising results with similar immunochemotherapy approaches in treating various cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hong Yang, M.D. Ph.D.
- Email: yanghong@sysucc.org.cn
- Phone: +8613560405144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.