Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or L… (NCT04263870) | Clinical Trial Compass
UnknownPhase 2
Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
China36 participantsStarted 2020-03
Plain-language summary
This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologic and/or cytologic diagnosis of unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction.
✓. Metastatic lesions are resectable or can be controlled by local ablative procedure.
✓. Definition of limited metastatic status:
✓. abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra aortic-caval, peripancreatic, or mesenterial lymph nodes).
✓. One incurable organ site with or without retroperitoneal lymph node metastases. One incurable organ site metastases according to the following schema： - Localized potentially operable peritoneal carcinomatosis or only cytology- positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis .
✓. Tumor HER-2 is negative.
✓. Age 18-75, gender unlimited.
✓. Survival expectation ≥12 weeks.
Exclusion criteria
✕.Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).
✕.5-year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma in situ).
✕.Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring immunosuppressive therapy for organ transplantation). However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter the group.
✕.Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
✕.Before the first administration of the study drug and who had a history of active tuberculosis infection more than one year ago were considered suitable for inclusion if they were judged by the investigator to have no evidence of active tuberculosis at present.
✕.Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by infection).
✕.The combination of serious internal and external diseases, affecting organ function, the researchers think it is not suitable to participate in this clinical trial.
✕.Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are unwilling to take contraceptive measures.