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Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer

ConditionGastric (Stomach) Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. The purpose of this study is to evaluate whether adding anti-angiogenic drugs or chemotherapy drugs on the basis of two-drug chemotherapy regimen (XELOX regimen) and PD-1 monoclonal antibody can improve efficacy for advanced gastric cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged over than 18 years

Histologically or cytologically confirmed gastric adenocarcinoma (including GEJ adenocarcinoma)

Presence of measurable lesions(RECIST 1.1)

Newly diagnosed patients; or patients with recurrence after surgery, who have been off adjuvant chemotherapy for at least 6 months and have not received any anti-cancer treatment within the past 6 months

Disqualifiers

Histopathological assessment of HER2 positivity (immunohistochemistry 3+ or immunohistochemistry 2+ and FISH positive)

Known dMMR/MSI-H

History of other malignant neoplasms within 3 years prior to enrollment, except for cured cervical carcinoma in situ or basal cell carcinoma

Presence of brain metastases to meninges

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib

    Drug

    Patients were randomized in a 1:1:1 ratio to three treatment groups: control group A: pembrolizumab combined with XELOX regimen, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles. Group B: treatment regimen was pembrolizumab combined with Nab-POF regimen, the regimen was repeated every 2 weeks, and tumor efficacy was evaluated every 3 treatment cycles. Group C: treatment regimen was pembrolizumab combined with XELOX regimen and lenvatinib, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles.

Treatment groups

141 Participants
are divided into 3 treatment groups
Group A: XELOX regimen plus sintilimabActive comparator 1 intervention
Group B: Nab-POF regimen plus sintilimabExperimental treatment 1 intervention
Group C: XELOX regimen plus sintilimab plus lenvatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

he proportion of patients whose tumor decrease to a certain size and remained for a certain period of time, including those with complete response (CR) and partial response (PR)

Time frame
the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 24 months

Secondary outcomes

1

Overall survival

Time frame
the duration from the date of randomization to the date of death due to any cause,assessed up to 48 months
2

Progression-free survival time

Time frame
the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 48 months
3

Disease control rate

assessed based on the RECIST 1.1 criteria, including complete response, partial response, and stable disease

Time frame
the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 24 months

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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