Health TrialsbyHealthPanel

Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy

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

About this trial

This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

2. Patients who have previously failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, and have maintained first-line use of immune checkpoint inhibitors for at least 3 months;

3. 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);

4. ECOG score: 0-1 point;

Disqualifiers

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

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

3. History of allergies to any component of Adebrelimab in the past;

Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab Injection: 1200mg, i.v.gtt, d1, Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.

  • Irinotecan

    Drug

    Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.

  • Malic acid Famitinib

    Drug

    Malic acid Famitinib: 20mg, po, d1-21.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 3 interventions
Group B: Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression free survival

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
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
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
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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