A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment fo… (NCT04934618) | Clinical Trial Compass
UnknownPhase 2
A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer
China85 participantsStarted 2020-05-19
Plain-language summary
The purpose of this study was to evaluate the overall survival time (OS), objective remission rate（ORR）, progression-free survival time（PFS）, disease control rate（DCR）of Carelizumab combined with irinotecan and apatinib for the second-line treatment of locally advanced unresectable, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction. At the same time, the safety and tolerance of the scheme were preliminarily evaluated.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
✓. After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
✓. At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
✓. Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
✓. Age ≥18 years old and ≤75 years old.
✓. The ECOG score is 0 or 1.
✓. The estimated survival time is ≥3 months.
✓. Within 7 days before entering the group, the laboratory test value met the chemotherapy standard.
Exclusion criteria
✕. Participate in other intervention clinical studies at the same time (unless participating in observation studies or being in the follow-up stage of intervention studies), and have received second-line treatment.
✕. have received antibody therapy of PD-1, PD-L1, PD-L2, CTLA4, CD137 or any other antibody or drug therapy with t cell co-stimulation or immune checkpoint pathway as specific target.
✕. It is known to be allergic to any monoclonal antibody or adjuvant.
✕
What they're measuring
1
Overall Suvival time（OS）
Timeframe: Up to 24 months
Trial details
NCT IDNCT04934618
SponsorNanfang Hospital, Southern Medical University
. Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
✕. Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.
✕. Receive live attenuated vaccine within 4 weeks before the first administration or during the planned study treatment.
✕. Received transplantation of solid organs or blood system.
✕. Active, known or suspected autoimmune diseases or related medical history in the past 2 years (vitiligo, psoriasis, alopecia or Graves' disease that does not require systematic treatment in the past 2 years, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes patients who only need insulin replacement therapy can enter Group).