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Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma

ConditionGastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have fully understood the study and voluntarily signed the informed consent;

Age ≥18 years old;

Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment;

Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment);

Disqualifiers

Failure to comply with the study protocol or study procedure;

Previous treatment with VEGFR inhibitors;

Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);

Known HER-2 positive patients;

Trial population

Patients with advanced gastric/gastroesophageal junction adenocarcinoma who failed treatment with anti-PD-1 /PD-L1 regimen.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PD-1inhibitor

    Drug

    PD-1 antibody was selected according to first-line drug use

  • Fruquintinib

    Drug

    a small molecular anti-tumor angiogensis drug

  • albumin paclitaxel

    Drug

    a kind of cytotoxic chemotherapy drug

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Fruquintinib + albumin paclitaxel2 interventions
Group B: Fruquintinib + albumin paclitaxel + PD-1 antibody3 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression free survival

Time frame
2 years

Secondary outcomes

1

ORR

Objective Remission Rate

Time frame
2 years
2

DCR

Disease Control Rate

Time frame
2 years
3

DoR

Duration of Remission

Time frame
2 years
4

OS

overall survival

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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