NCT07669740

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
29mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

January 9, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 25, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 9, 2026

Last Update Submit

June 22, 2026

Conditions

Gastric Cancer (Diagnosis)

Keywords

gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

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

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

Secondary Outcomes (1)

  • Progression-Free Survival (PFS)

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

Study Arms (1)

A Study on the Efficacy and Safety of Sintilimab Combined with Ramucirumab and Paclitaxel in the Tre

EXPERIMENTAL

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

Drug: Sintilimab Combined with Ramucirumab and Paclitaxel

Interventions

Sintilimab Combined with Ramucirumab and PaclitaxelDRUG

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

A Study on the Efficacy and Safety of Sintilimab Combined with Ramucirumab and Paclitaxel in the Tre

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Disease recurrence during adjuvant chemotherapy or within 6 months after completion of adjuvant chemotherapy.
  • At least one measurable lesion according to RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate organ and bone marrow function.
  • Life expectancy of at least 3 months.
  • Ability to understand and willingness to sign written informed consent.

You may not qualify if:

  • 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.
  • Uncontrolled cardiovascular disease or uncontrolled hypertension.
  • History of thromboembolic events or clinically significant bleeding disorders within 6 months prior to enrollment.
  • Active tuberculosis or interstitial lung disease.
  • Known hypersensitivity to monoclonal antibodies or any excipients of the study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsDisease

Interventions

RamucirumabPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Hao Wu

CONTACT

13913855335whdactor@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

June 25, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

June 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CN(1)