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Apatinib Plus Toripalimab (Anti-PD1 Therapy) as Second-Line Therapy in Patients With Advanced Gastric or
Qing Wei1,2, Xiaoqing Xu1, Jingjing Li1
1Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, People's Republic of China.
Background:
This study aimed to assess the activity of apatinib plus toripalimab in the second line for patients with advanced gastric or esophagogastric junction cancer (GC/EGJC).
Methods:
In this open-label, phase II, randomized trial, patients with advanced GC/EGJC who progressed after first-line chemotherapy were enrolled and received 250 mg apatinib per day plus 240 mg toripalimab on day 1 per 3 weeks (arm A) or physician's choice of chemotherapy (PC, arm B). The primary endpoint of this study was the 1-year survival rate. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and safety were assessed as secondary endpoints.
Results:
Twenty-five patients received apatinib plus toripalimab while 26 were enrolled in arm B. The 1-year survival rates of the 2 groups were 43.3% and 42.3%, respectively (P = .903). The PFS was 2.77 versus 2.33 months (P = .660). The OS was 8.30 versus 9.88 months (P = .539). An objective response was reported in 20.0% of patients in arm A compared to 26.9% in arm B (P = .368), respectively. A total of 6 (24.0%) patients experienced adverse events of grade ≥ 3 in arm A, while 9 (34.6%) patients suffered from adverse events of grade ≥ 3 in arm B. No drug-related deaths occurred in either group.
Conclusion:
Toripalimab plus apatinib treatment in second-line therapy of advanced GC/EGJC showed manageable toxicity but did not improve clinical outcomes relative to PC treatment (ClinicalTrials.gov Identifier: NCT04190745).
Insights
Apatinib plus toripalimab did not improve survival rates in advanced gastric cancer patients compared to chemotherapy. This combination therapy demonstrated manageable toxicity but did not offer superior clinical outcomes in the second-line setting.
Area of Science:
- Oncology
- Clinical Trials
- Gastrointestinal Oncology
Background:
- Advanced gastric or esophagogastric junction cancer (GC/EGJC) presents a significant therapeutic challenge.
- Second-line treatment options for patients progressing after initial chemotherapy require further investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of apatinib combined with toripalimab as a second-line treatment for advanced GC/EGJC.
- To compare the 1-year survival rate of apatinib plus toripalimab versus physician's choice chemotherapy.
Main Methods:
- An open-label, phase II, randomized trial involving patients with advanced GC/EGJC who progressed after first-line chemotherapy.
- Arm A received daily apatinib plus toripalimab every 3 weeks; Arm B received physician's choice of chemotherapy.
- Primary endpoint was 1-year survival rate; secondary endpoints included progression-free survival, overall survival, objective response rate, and safety.
Main Results:
- The 1-year survival rates were 43.3% for apatinib/toripalimab and 42.3% for chemotherapy (P=.903).
- Progression-free survival (2.77 vs 2.33 months) and overall survival (8.30 vs 9.88 months) were not significantly different between groups.
- Objective response rates were 20.0% and 26.9%, with manageable grade ≥3 adverse events in both arms.
Conclusions:
- Apatinib plus toripalimab did not demonstrate superior clinical outcomes compared to physician's choice chemotherapy in the second-line treatment of advanced GC/EGJC.
- The combination therapy exhibited manageable toxicity profiles.
- Further research may be needed to identify patient subgroups who could benefit from this combination therapy.
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