Health TrialsbyHealthPanel

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

ConditionsGastric CancerSecond-line Therapy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Camrelizumab

    Drug

    Camrelizumab 200mg，d1，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 use for Carilizumab is 2 years

  • Nab paclitaxel

    Drug

    nab-paclitaxel 100mg/m2 D1、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 treatment time for albumin bound paclitaxel is 6-8 cycles.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

mPFS

median Progression free survival

Time frame
[Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years]

Secondary outcomes

1

mOS

median survival time

Time frame
[Time Frame: The longest follow-up period from the patient's enrollment to death from any cause is 2 years]
2

DCR

Disease Control Rate

Time frame
[Time Frame: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months]
3

safety：Record the incidence rate of all adverse events

Record the incidence rate of all adverse events

Time frame
[Time Frame: From enrollment until 90 days after the last dose of medication]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Tumor Hospital

Lead sponsor

Source ClinicalTrials.gov
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