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NCT05025033
Chemotherapy Combined With Apatinib and PD-1 Antibody
Phase 2 trial testing PD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate in Gastric Cancer in 30 participants. Completed in 30 April 2022.
30 January 2022
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 30 May 2019 |
| Primary completion | 30 January 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- PD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05025033
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Tianjin Medical University Cancer Institute and Hospital trials
Trials by the same sponsor.
- NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
- NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05025033 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital
- Last refreshed: 18 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05025033.
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