Evidence map›Paper›PMID 41206442›Full record

Trial reportBMC cancer2025

Toripalimab combined with FLOT chemotherapy as conversion therapy for gastric cancer with peritoneal metastasis: a single-arm, open-label, phase II trial.

Zijing Zhang, Zeyu Lin, Yuting Xu, Lijie Luo, Haiping Zeng, Wenjun Xiong, Yan Chen, Yaohui Peng, Tingting Yang, YanSheng Zheng and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04886193 (Docetaxel, Oxaliplatin, Fluorouracil), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT04886193 naunknown statusnot on this map

Docetaxel, Oxaliplatin, Fluorouracil (FLOT Regimen) Combined With Teriprizumab (PD-1) in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis: an Open, One-arm, Exploratory Study

TypeinterventionalSponsorGuangdong Provincial Hospital of Traditional Chinese MedicineRan2021 to 2023Enrolled20ConditionsChemotherapy, Gastric CancerArmsFLOT(Docetaxel+oxaliplatin+leucovorin+5-FU), Treprizumab, Tiggio capsule (S-1)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Zijing Zhang *Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Zeyu Lin *The First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou, China.
Yuting Xu *Anorectal Department, Zhongshan Hospital of Chinese Medicine, Zhongshan, China.
Lijie LuoDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Haiping ZengDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Wenjun XiongDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Yan ChenDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Yaohui PengDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Tingting YangSecond Department of General Surgery, Zhongshan City People's Hospital, Zhongshan, China.
YanSheng ZhengDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Jin LiDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China.
Haipeng HuangDepartment of Colorectal Surgery, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Wei WangDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China. Wangwei16400@163.com.

Funding

Guangzhou University of Chinese Medicine's "Peak Creation" Project: Promoting the Emergence of Major Achievements GZY2025ZJ30Research Project of Traditional Chinese Medicine Bureau Of Guangdong Province 20231098the Supporting Scientific Research Funds of the First Affiliated Hospital of Guangzhou University of Chinese Medicine 09005647001
6 · The paper itself

Abstract

backgroundThe combination of PD-1/PD-L1 monoclonal antibodies and chemotherapy has established a new standard of care for the first-line treatment of patients with unresectable locally advanced or metastatic gastric cancer (GC) and gastro-oesophageal junction adenocarcinoma. However, peritoneal metastasis represents a distinct pattern of dissemination in GC, typically associated with a poor prognosis. Whether the combination regimen improves survival for patients with concomitant peritoneal metastasis remains controversial. This study aims to evaluate the efficacy and safety of toripalimab (an anti-PD-1 monoclonal antibody) combined with FLOT chemotherapy as conversion therapy in these patients.

methodsIn this single-arm, open-label, phase II trial conducted in China, we enrolled patients aged 18–80 years with laparoscopically proven gastric cancer and peritoneal metastasis. Patients received toripalimab (3 mg/kg) plus FLOT chemotherapy (docetaxel 50 mg/m2; oxaliplatin 85 mg/m2; leucovorin 200 mg/m2, 5-FU 2600 mg/m2) every 14 days for up to 4 cycles, followed by surgical resection. Patients who underwent surgery subsequently received 4 cycles of adjuvant treatment. The primary endpoint was the R0 resection conversion rate. The secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety.

resultsBetween April 2021 and April 2023, 24 patients were screened, 20 of whom were included in this analysis. The median follow-up was 10.8 months. The objective response rate (ORR) was 35% and the disease control rate (DCR) was 80%. The R0 resection conversion rate after treatment was 25% (5/20), 40% (2/5) participants achieved TRG1 and 60% (3/5) participants achieved TRG2. The median PFS and OS were 6.5 and 10.8 months, respectively. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 35% of participants.

conclusionsToripalimab combined with FLOT chemotherapy demonstrated potential conversion efficacy in the treatment of gastric cancer with peritoneal metastasis. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov (NCT04886193). Date of registration: 13 May 2021.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsPeritoneal NeoplasmsStomach NeoplasmsAdultAgedAged, 80 and overDocetaxelFemaleFluorouracilHumansLeucovorinMaleMiddle AgedOxaliplatinProgression-Free SurvivalAntibodies, Monoclonal, HumanizedDocetaxelFluorouracilLeucovorinOxaliplatintoripalimabConversion therapyFLOTGastric cancerPeritoneal metastasisToripalimab

Identifiers

PMID41206442
PMCPMC12595676

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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.