Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sintilimab
DrugSintilimab 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
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant chemo-immunotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic Complete Response
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Time frame
From date of enrollment until one month after resectionSecondary outcomes
1
Overall survival
The time from randomization to death from any cause.
Time frame
2-5 years2
Disease-Free-Survival
The time between the beginning of treatment and the observation of disease progression or death from any cause.
Time frame
2-5 years3
R0 resection rate
The percentage of patients who undergo complete resection
Time frame
From date of enrollment until one month after resectionSponsors and contacts
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Source ClinicalTrials.gov