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Clinical Study on the Combination of Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer Patients Who Have Received/Not Received Immunotherapy in the Past

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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);

• ECOG score: 0-1 point;

• Expected survival period ≥ 12 weeks;

• The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);

• Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Carilizumab, and at least 6 months after the last use of chemotherapy;

• HER2 negative;

⁃ Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Locations
Other Locations
China
Shandong First Medical University Affiliated Cancer Hospital
RECRUITING
Jinan
Contact Information
Primary
Zuoxing Niu, Prof.
nzxsdth@163.com
+86 13506413687
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Group 1
Subjects with advanced gastric cancer who have been included in first-line treatment and have received systemic chemotherapy in the past.~Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w, Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.
Experimental: Group 2
Advanced gastric cancer subjects included in the first-line treatment progression, who have previously received systemic chemotherapy combined with immunotherapy in the first-line treatment Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w, Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.
Related Therapeutic Areas
Sponsors
Leads: Shandong Tumor Hospital

This content was sourced from clinicaltrials.gov