Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2026
Efficacy and safety of trastuzumab biosimilar CT-P6 plus SOX or CapeOX in HER2-positive advanced gastric cancer: a multicenter phase II KSCC-TROX study.
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTrastuzumab-based chemotherapy is the standard first-line treatment for HER2-positive advanced gastric cancer. While biosimilars of trastuzumab have demonstrated equivalent efficacy in breast cancer, their clinical utility in gastric cancer remains poorly characterized. The TROX study evaluated the efficacy and safety of a trastuzumab biosimilar (CT-P6) combined with SOX or CapeOX in this population.
methodsThis multicenter, open-label, non-comparative phase II trial enrolled patients with HER2-positive unresectable or recurrent gastric cancer who had not received prior chemotherapy. Patients were randomized to receive CT-P6 with either SOX (S-1 and oxaliplatin) or CapeOX (capecitabine and oxaliplatin). The primary endpoint was overall response rate (ORR), with a threshold ORR of 43% based on prior trastuzumab trials. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
resultsFrom May 2019 to November 2022, 67 patients were randomized; 34 in the SOX arm and 32 in the CapeOX arm were included in the efficacy analysis. The overall ORR was 77.3% (90% CI: 68.8–85.8%), exceeding the predefined threshold. The median PFS and OS were 9.0 months (95% CI: 6.5–10.7) and 18.6 months (95% CI: 15.1–23.1), respectively. Grade 3–4 adverse events included hypokalemia (18.2%), neutropenia (15.2%), anorexia (12.1%), and peripheral neuropathy (10.6%). No treatment-related deaths were reported.
conclusionsCT-P6 combined with SOX or CapeOX demonstrated high efficacy and manageable toxicity as first-line therapy for HER2-positive gastric cancer. This study supports the clinical use of trastuzumab biosimilars as cost-effective alternatives to originator biologics in gastric cancer treatment.
Indexed as
Identifiers
41870735What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.