Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University

About this trial

This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2 (CLDN18.2)-related regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily join this study, sign the informed consent form, and have good compliance;

Pathologically (histologically or cytologically) confirmed HER2/neu-negative (or HER2/neu status unclear) advanced gastric cancer or gastroesophageal junction adenocarcinoma;

Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN18.2 ADC or CLDN18.2 CART therapy, treatment regimen includes CLDN18.2 combined with chemotherapy or immunotherapy or other systemic therapy) and the time from the end of the last treatment with CLDN18.2-related drugs is more than two weeks;

According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion, which can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), with the longest diameter at baseline ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions);

Disqualifiers

Have any active autoimmune disease or history of autoimmune disease (such as but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; requiring bronchodilators for medical intervention of asthma); but the following patients are allowed to enroll: vitiligo, psoriasis, alopecia that do not require systemic treatment, type I diabetes that is well controlled, hypothyroidism that has normal thyroid function after replacement therapy;

Diagnosed with immunodeficiency or receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy (dose >10mg/day of prednisone or other equivalent hormones), and continuing to use it within 2 weeks before the first administration;

Received any live vaccine, attenuated vaccine (including anti-infective vaccines, such as influenza vaccine, varicella vaccine, etc.), or inactivated vaccine within 4 weeks before enrollment and plan to receive live vaccine/attenuated vaccine/inactivated vaccine during the study; used systemic immunostimulants (including but not limited to interferon and IL-2) within 2 weeks before the start of the study treatment;

Patients who have received anti-tumor treatment with traditional Chinese medicine within the past two weeks (the traditional Chinese medicine contains the following medicinal materials such as Brucea javanica, Coix seed, Lentinan, Cantharidin, Toad skin, Astragalus, Sophora, Ugonin, Chebula, Icariin, etc.), but patients who have stopped taking anti-tumor treatment with traditional Chinese medicine for more than two weeks are allowed to enroll;

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib

    Drug

    Anlotinib: 12mg PO, QD, D1-14, Q3W;

  • TQB2450

    Drug

    TQB2450: 1200 mg, IV, D1, Q3W

  • Albumin-Bound Paclitaxel

    Drug

    125mg/m2 IV D1,8,Q3W

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Anlotinib, TQB2450 and Albumin-bound PaclitaxelExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective Response Rate (ORR) is defined as the percentage of participants who achieve either a complete response (CR) or a partial response (PR) according to the RECIST 1.1 criteria.

Time frame
Baseline to CR/PR, about 12 months

Secondary outcomes

1

DCR

Disease Control Rate (DCR) is defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD).

Time frame
Baseline to CR/PR, about 16 months
2

PFS

Progression-free survival (PFS) is the time elapsed between treatment initiation and tumor progression or death from any cause based on the RECIST 1.1 criteria.

Time frame
Baseline to CR/PR, about 16 months
3

OS

Overall Survival (OS) is defined as the time from the first dose of study drugs to the time of death from any cause.

Time frame
Baseline to CR/PR, about 20 months
4

Adverse events

The adverse events (AEs) were assessed by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
Baseline to CR/PR, about 20 months

Other outcomes

Sponsors and contacts

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

Peking University

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: