Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Tumor Hospital

About this trial

This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.

Eligibility criteria

Qualifiers

Age range: 18 to 75 years old, both male and female are acceptable;

Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;

Gastric cancer patients who have previously received first-line systemic chemotherapy (queue 1) or systemic chemotherapy combined with immunotherapy (queue 2) for progression; For intervention group 2, the best response to first-line immunotherapy is CR or PR or SD ≥ 3 months;

According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);

Disqualifiers

History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;

There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;

History of allergies to monoclonal antibodies, any component of Carilizumab, or albumin bound paclitaxel;

Patients who have experienced serious adverse reactions to immunotherapy in the past and are deemed unsuitable for continued use of immunotherapy by the researchers;

Trial design

Treatments tested in this trial

  • Camrelizumab
  • Nab paclitaxel

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators