Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma

Esophagogastric Junction Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170503
• Other study ID #: SYSUCC B2021-356-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 29, 2021
• Est. completion date: January 1, 2029

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: Hong Yang, M.D. Ph.D.
• Phone: +8613560405144
• Email: yanghong[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma

Intervention

Drug:
• Sintilimab
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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response	No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes	From date of enrollment until one month after resection
Secondary	Overall survival	The time from randomization to death from any cause.	2-5 years
Secondary	Disease-Free-Survival	The time between the beginning of treatment and the observation of disease progression or death from any cause.	2-5 years
Secondary	R0 resection rate	The percentage of patients who undergo complete resection	From date of enrollment until one month after resection