Evidence map›Paper›PMID 39536755›Full record

Trial reportMed (New York, N.Y.)2025

Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study.

Bo Long, Huinian Zhou, Zeyuan Yu, Junmin Zhu, Hanteng Yang, Zeping Huang, Dengwen Wei, Shigong Chen, Xiaojun Yang, Xiaoning Zhao and 15 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Med (New York, N.Y.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 7 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Bo LongLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Huinian ZhouLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Zeyuan YuLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Junmin ZhuLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Hanteng YangLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Zeping HuangLanzhou University Second Hospital, The Oncological Surgery Department, Lanzhou, China.
Dengwen WeiSun Yat-sen University Cancer Center Gansu Provincial Cancer Hospital, The Gastrointestinal Surgery Department, Lanzhou, China.
Shigong ChenLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Xiaojun YangGansu Provincial Hospital, The General Surgery Department, Lanzhou, China.
Xiaoning ZhaoSun Yat-sen University Cancer Center Gansu Provincial Cancer Hospital, The Gastrointestinal Surgery Department, Lanzhou, China.
Wenjuan ZhangLanzhou University Second Hospital, The Radiology Department, Lanzhou, China.
Hong YanLanzhou University Second Hospital, The Pathology Department, Lanzhou, China.
Xiaoying GuanLanzhou University Second Hospital, The Pathology Department, Lanzhou, China.
Long LiLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Gengyuan ZhangLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Hongwei YuLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Shengfu CheLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Zhongti GaoLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Xiangyan JiangLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Changjiang LuoLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Jie MaoLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China.
Da ZhaoThe First Hospital of Lanzhou University, The Oncology Department, Lanzhou, China.
Yumin LiLanzhou University Second Hospital, The Oncological Surgery Department, Lanzhou, China.
Zebin JiangGansu Provincial Hospital, The General Surgery Department, Lanzhou, China.
Zuoyi JiaoLanzhou University Second Hospital, The General Surgery Department, Lanzhou, China; Biobank of Tumors from Plateau of Gansu Province, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: jiaozy@lzu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment with cadonilimab and chemotherapy has shown promise as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. However, its application in neoadjuvant settings has not yet been documented.

methodsThis multicenter, phase 2 trial (ChiCTR2200066893) was conducted at four hospitals across China. Treatment-naive patients with locally advanced G/GEJ adenocarcinoma (cT3/4, N+, M0) and who were human epidermal growth factor receptor 2 negative received 3-cycle or 4-cycle neoadjuvant treatment of cadonilimab plus FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy, followed by gastrectomy and 4-cycle adjuvant FLOT chemotherapy. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), R0 resection rate, downstaging rate, and safety.

findingsBetween December 23, 2022, and December 15, 2023, 32 of 38 patients completed the scheduled treatment, achieving an R0 resection rate of 100% (32/32). The pCR rate was 21.1% (8/38, 90% confidence interval [CI]: 9.7-32.4), and the MPR rate was 44.7% (17/38, 90% CI: 30.9-58.5). Radiological evaluations were available for 28 of 38 patients by blinded independent central review. The ORR was 60.7% (17/28, 90% CI: 44.7-76.7), and the DCR was 100.0% (28/28, 90% CI: 100.0-100.0). Tumor downstaging occurred in 71.9% of patients (23/32), with consistent efficacy across all populations observed in the subgroup analysis. Grade 3 adverse events occurred in 31.6% of patients without severe safety issues.

conclusionsNeoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.

fundingThis study was funded by Akeso Biopharma.

Indexed as

AdenocarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionNeoadjuvant TherapyStomach NeoplasmsAdultAgedChemotherapy, AdjuvantDocetaxelFemaleFluorouracilGastrectomyHumansLeucovorinAntibodies, Monoclonal, HumanizedDocetaxelFluorouracilLeucovorinOxaliplatincadonilimabdual anti-PD-1/CTLA-4 therapyFLOT chemotherapygastric/gastroesophageal junction adenocarcinomaimmunotherapyneoadjuvant treatmentTranslation to patients

Identifiers

PMID39536755

What OpenQuestion holds

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Registered trials

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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.