A Study on the Efficacy and Safety of Sintilimab Combined With Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients With Short-term Recurrence After Adjuvant Therapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

To explore the efficacy and safety of sintilimab combined with ramucirumab and paclitaxel in the treatment of advanced gastric cancer patients with short-term recurrence after postoperative adjuvant therapy, and to identify efficacy-related biomarkers to guide subsequent individualized treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of informed consent.

Histologically confirmed gastric or gastroesophageal junction (GEJ)adenocarcinoma.

HER2-negative disease, as determined by standard testing methods.

Prior D2 radical gastrectomy with R0 resection.

Disqualifiers

Active malignancy within the past 5 years, except for adequately treated in situ carcinoma or other cancers with a negligible risk of recurrence.

Prior participation in another investigational drug study within 4 weeks prior to enrollment.

Symptomatic central nervous system (CNS) metastases.

Active autoimmune disease requiring systemic treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab Combined with Ramucirumab and Paclitaxel

    Drug

    Sintilimab Combined with Ramucirumab and Paclitaxel in the Treatment of Gastric Cancer Patients with Short-term Recurrence after Adjuvant Therapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: A Study on the Efficacy and Safety of Sintilimab Combined with Ramucirumab and Paclitaxel in the TreExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1.

Time frame
From baseline until disease progression or study completion, assessed up to 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival is defined as the time from baseline to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
From treatment initiation until disease progression or death, whichever occurs first, assessed up to 24 months

Other outcomes

Sponsors and contacts

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