NCT04267549

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Status unknown Phase 2 Last updated 6 July 2023

What this trial tests

Phase 2 trial testing sintilimab in Gastric Cancer Stage IV in 47 participants. Status unknown.

Timeline

1 May 2019

Primary endpoint
1 December 2022

30 August 2023

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	1 May 2019
Primary completion	1 December 2022
Estimated completion	30 August 2023
Sites	1 location across China

Drugs / interventions tested

• sintilimab — full drug profile →
• apatinib (Apatinib) — full drug profile →
• S1 — full drug profile →
• Nab paclitaxel

Conditions studied

• Gastric Cancer Stage IV — all drugs for Gastric Cancer Stage IV →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

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

Sponsor's own description

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.

Publications & conference data

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

1. The integration of immune checkpoint inhibitors with VEGF targeted agents in advanced gastric and gastroesophageal adenocarcinoma: a review on the rationale and results of early phase trials.
   Saeed A, Park R, Sun W. · · 2021 · cited 74× · PMID 33436042 · DOI 10.1186/s13045-021-01034-0
2. The Role and Expression of Angiogenesis-Related miRNAs in Gastric Cancer.
   Giuppi M, La Salvia A, Evangelista J, Ghidini M. · · 2021 · cited 20× · PMID 33673057 · DOI 10.3390/biology10020146
3. Enhancing the Potential of Immunotherapy in Paediatric Sarcomas: Breaking the Immunosuppressive Barrier with Receptor Tyrosine Kinase Inhibitors.
   Fleuren EDG, Terry RL, Meyran D, Omer N, et al · · 2021 · cited 9× · PMID 34944614 · DOI 10.3390/biomedicines9121798
4. Primary Tumor Resection for Metastatic Colorectal, Gastric and Pancreatic Cancer Patients: In Search of Scientific Evidence to Inform Clinical Practice.
   Fanotto V, Salani F, Vivaldi C, Scartozzi M, et al · · 2023 · cited 8× · PMID 36765854 · DOI 10.3390/cancers15030900
5. Conversion therapy with sintilimab combined with chemotherapy and apatinib in stage IV gastric cancer.
   Liu Y, Xue Q, Wang B, Ding X, et al · · 2025 · cited 2× · PMID 40605195 · DOI 10.1002/ijc.35511
6. Nanotherapeutics Plus Immunotherapy in Oncology: Who Brings What to the Table?
   Timon-David E, Perez C, Rodallec A. · · 2022 · cited 2× · PMID 36365144 · DOI 10.3390/pharmaceutics14112326
7. Progress of immune checkpoint inhibitors in gastric cancer.
   Wan JY, Zhang D, Wu XH, Yang H, et al · · 2025 · cited 1× · PMID 40837753 · DOI 10.4251/wjgo.v17.i8.109613
8. Immunotherapy Based on Immune Checkpoint Molecules and Immune Checkpoint Inhibitors in Gastric Cancer–Narrative Review
   Poniewierska-Baran A, Sobolak K, Niedźwiedzka-Rystwej P, Plewa P, et al · · 2024