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NCT05025033

Chemotherapy Combined With Apatinib and PD-1 Antibody

Completed Phase 2 Last updated 18 January 2023
What this trial tests

Phase 2 trial testing PD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate in Gastric Cancer in 30 participants. Completed in 30 April 2022.

Timeline
30 May 2019
Primary endpoint
30 January 2022
30 April 2022

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date30 May 2019
Primary completion30 January 2022
Estimated completion30 April 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 75, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effective rate of second-line and later-line single-agent therapy for advanced gastric cancer is limited. This research plan aims to explore whether the combination of drugs can further improve the benefits of second-line and above therapies. Previous studies have shown that there is a significant synergistic effect between chemotherapy and PD-1 monoclonal antibody, or anti-angiogenic TKI drugs and PD-1 monoclonal antibody. This project is planned to be based on the classic chemotherapy drugs irinotecan or paclitaxel, combined with mesylate Apatinib and PD-1 monoclonal antibody, explore the effectiveness and safety of this three-drug combination regimen for the second-line and above treatment of advanced gastric cancer, in order to provide a better late-line treatment plan for patients with advanced gastric cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sintilimab Plus Apatinib and Chemotherapy as Second‑/Third-Line treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a prospective, Single-Arm, phase II trial.
    Zhang L, Wang W, Ge S, Li H, et al · · 2023 · cited 17× · PMID 36872337 · DOI 10.1186/s12885-023-10661-4
  2. Immunotherapy combined with apatinib in the treatment of advanced or metastatic gastric/gastroesophageal tumors: a systematic review and meta-analysis.
    Wang J, Lin J, Wang R, Tong T, et al · · 2024 · cited 3× · PMID 38760737 · DOI 10.1186/s12885-024-12340-4
  3. Unlocking the potential: current landscape and future directions of immunotherapy in gastric cancer.
    Zhou Y, Wei L, Wang L, Zhang B, et al · · 2026 · PMID 42206056 · DOI 10.3389/fimmu.2026.1742723
  4. Innovative Immunotherapy and Its Transformative Impact on Gastric Adenocarcinoma: A Comprehensive Review of the Disease's Origins, Epidemiology, Classification, Diagnosis, and Treatment Options.
    Upasana, Kanugo A, Bhattacharya S. · · 2025 · PMID 40534682 · DOI 10.1021/acsptsci.4c00677
  5. Sintilimab Plus Apatinib and Chemotherapy as Second‑/Third-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single- Arm, Phase II Trial
    Zhang L, Wang W, Ge S, Li H, et al · · 2022 · DOI 10.21203/rs.3.rs-2052138/v1

Verify or expand the search:

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

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Data sources for this page

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