Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectab… (NCT04631757) | Clinical Trial Compass
UnknownPhase 2
Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
33 participantsStarted 2020-12-15
Plain-language summary
This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who provided written informed consent to be subjects in this trial.
* 18-75 years old.
* Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
* The initial unresectable or potentially resectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) in clinical stage T3-4N+M0 (AJCC 8 edition TNM stage) under any following condition: serious primary tumor invasion, unresectable bulky lymph node, retroperitoneal lymph node metastasis (RPLM). Clinical staging was performed according to enhanced CT/MRI examination.
* No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (include but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
* Plan to have surgery after conversion therapy.
* Patients capable of taking oral medication.
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Survival expectation ≥12 months.
* Adequate organ function according to the following laboratory test results: absolute neutrophil count (ANC) ≥1.5×109/L; platelets ≥80×109/L; hemoglobin ≥90g/L; total bilirubin ≤1.5 ULN; serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance \> 50ml/min.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to rece…
What they're measuring
1
1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment
Timeframe: Up to approximately 12 months
Trial details
NCT IDNCT04631757
SponsorTianjin Medical University Cancer Institute and Hospital