A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Age: 18 ~ 75 years old, male and female;

2) ECOG score: 0 or 1;

3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;

4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD;

Disqualifiers

1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;

2) HER2-positive patients;

3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;

4) Patients with severe liver and kidney insufficiency or heart insufficiency;

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel for injection (albumin-bound)

    Drug

    100 mg/m2, day 1, day 8, every 21 days for a cycle.

  • Adebrelimab

    Drug

    20mg/kg or 1200mg, the first day, every 21 days as a cycle.

  • Apatinib mesylate

    Drug

    250mg once a day for 5 consecutive days and discontinue for 2 days

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.

Time frame
1 years

Secondary outcomes

1

Disease control rate(DCR)

Refers to the proportion of all subjects with the best overall response (BOR) according to RECIST1.1 criteria as complete remission (CR), partial remission (PR) and stable disease (SD).

Time frame
1 years
2

Progression-free survival (PFS)

PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by RECIST1.1 criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.

Time frame
1 years
3

Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR)

It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause.

Time frame
1 years
4

Overall survival(OS)

Defined as the time from the date of the first dose to the death of the subject from any cause.

Time frame
2 years

Other outcomes

1

Explore potential biomarkers in tumor tissue

ORR corresponding to PD-L1 negative expression, positive expression (TPS≥1%), low expression (\<10%), high expression (TPS\>50%)

Time frame
1 years

Sponsors and contacts

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