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This study aims to evaluate the effectiveness of chemotherapy combined with tislelizumab as a first-line treatment for gastric cancer with liver metastasis.

May 30, 2026

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A multi-center phase II study of chemotherapy (SOX) plus tislelizumab as first-line therapy for gastric cancer with liver metastasis.

MKMuxing KangSecond Affiliated Hospital of Zhejiang University GCGuoFeng ChenSecond Affiliated Hospital of Zhejiang University XLX D LiuZhejiang International Studies University

Key Points

This study aims to evaluate the effectiveness of chemotherapy combined with tislelizumab as a first-line treatment for gastric cancer with liver metastasis.
Single-arm phase II trial enrolling patients with untreated synchronous gastric cancer and liver metastasis.
Participants received SOX chemotherapy plus tislelizumab for 8 cycles followed by maintenance of S-1 and tislelizumab.
Primary endpoint was objective response rate, with secondary endpoints including disease control rate, progression-free survival, and overall survival.
Objective response rate achieved was 73.33% (22/30).
Median progression-free survival was 21.00 months (95% CI 14.13-27.87) and median overall survival was 24.00 months (95% CI 14.18-33.82).
Conversion surgery was performed in 33.33% of patients (10/30), with significantly better survival outcomes noted (P=0.004 for OS, P=0.005 for PFS).

Abstract

e16047 Background: Grim prognosis and medical scarcities of gastric cancer (GC) with liver metastasis (LM) presents the significant challenge. Chemotherapy plus programmed cell death inhibitors provided promising opportunities to solve such problems and the dedicated trail is warranted. Methods: In this prospective, single-arm phase 2 trail, untreated synchronous GC-LM are eligible and receive SOX plus Tisleizumab (200mg, Q3W) for 8 cycles, maintenance therapy is S-1 within 1 year plus Tisleizumab within 2 years, or until disease progression. The primary endpoint was objective response rate (ORR), secondary endpoints included disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). This exploratory study hypothesized chemotherapy plus tislelizumab would increase ORR from 25% to 56%, with one-sided α of 0.05, statistical power of 0.8, considering 10% dropout, 33 patients are required. Results: 34 patients were enrolled and 4 patients were excluded from efficacy analysis (3 withdrawal of consent, 1 loss to follow-up). Median follow-up was 24.00m (14.18-33.82, 95%CI). ORR is 73.33% (22/30) and DCR is 86.67% (26/30). Median PFS and OS is 21.00m (14.13-27.87) and 24.00m (14.18-33.82). Mean maximal tumor volume regression of GC is 36.17% and the time to reach maximal tumor regression is 3.5m, correspondingly, 46.67% and 3.87m are observed in LM. 33.33% (10/30) patients received conversion surgery (CS) and TRG0 ratio is 16.67% (5/30). CS has significantly better median OS (P = 0.004) and median PFS/DFS (P = 0.005). Conclusions: Chemotherapy (SOX) plus Tisleizumab as first line treatment of GC-LM demonstrated clinically meaningful benefits in both treatment response and prolonged survival. Particularly, increased CS rate provided additional survival benefits. Clinical trial information: NCT05325528 . N MedianOS (95% CI) P-value MedianPFS (95% CI) P-value All patients 30 Age ≥65 18 28.00 (NR-NR) 0.129 21 (NR-NR) 0.273 ＜65 12 20.00 (NR-NR) 16.00 (NR-NR) Sex Female 3 28.00 (10.17-45.83) 0.526 17.00 (NR-NR) 0.525 Male 27 24.00 (NR-NR) 21.00 (1.37-40.63) N stage N1-2 18 24.00 (NR-NR) 0.710 17.00 (NR-34.31) 0.736 N3a&b 12 28.00 (NR-NR) 21.00 (NR-NR) Gastric tumor diameter<5cm 14 32.48 (NR-NR) 0.068 <jats:td colspan="1

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A multi-center phase II study of chemotherapy (SOX) plus tislelizumab as first-line therapy for gastric cancer with liver metastasis.

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Abstract

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