Evidence map›Paper›PMID 40450051›Full record

Trial reportNature communications2025

Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial.

Ke Liu, Bao-Dong Qin, Shi-Qi Chen, Xue Zhong, Xiao-Peng Duan, Ying Wu, Zhan Wang, Yan Ling, Li Sun, Chen-Yang Ye and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04278222 (Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04278222 phase2unknown statusnot on this map

Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial

TypeinterventionalSponsorShanghai Changzheng HospitalRan2020 to 2024Enrolled24ConditionsGastric Cancer, Immunotherapy, Anlotinib, ToripalimabArmsAnlotinib Plus Toripalimab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

14 authors.

Ke Liu *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Bao-Dong Qin *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Shi-Qi Chen *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xue Zhong *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xiao-Peng Duan *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.ORCID http://orcid.org/0000-0002-2421-1756
Ying Wu *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Zhan WangDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Yan LingDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Li SunDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Chen-Yang YeDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Dong-Min ShiDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ning Gao3D Medicines Inc, Shanghai, China.
Xiao-Dong JiaoDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China. 13817797639@139.com.
Yuan-Sheng ZangDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China. doctorzangys@163.com.ORCID http://orcid.org/0000-0002-9488-7305

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Evidence-guided regimens for advanced gastric cancer (AGC) in patients with performance status 2 (PS 2) are limited. Here, we proposed a structured therapeutic framework termed "performance status-matched strategy", and further conducted the APICAL-GC trial (NCT04278222). This open-label, single-arm phase II study evaluated the efficacy and safety of anlotinib combined with toripalimab among 24 treatment-naïve AGC patients with PS 2. The primary outcome was the objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile. This trial met its prespecified endpoints, demonstrating an ORR of 58.3% (95%CI 36.6-77.9) with a DoR of 12.1 months (range: 1.43-48.5), and a DCR of 95.8% (95%CI 78.9-99.9). Median PFS reached 7.33 months (95%CI 3.83-17.1), while median OS was 15.9 months (95%CI 7.73-23.2). Treatment-related adverse events (TRAEs) of any grade occurred in 21 patients (87.5%), with grade-3 TRAEs observed in 7 patients (29.2%). No grade-4/5 TRAEs were reported. These findings provide a rationale for anlotinib plus toripalimab as a promising chemotherapy-free option for the first-line treatment of AGC patients with PS 2 under the performance status-matched strategy, showing comparable anticancer activity and a lower occurrence rate of TRAEs.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsIndolesQuinolinesStomach NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalTreatment OutcomeanlotinibAntibodies, Monoclonal, HumanizedIndolesQuinolinestoripalimab

Identifiers

PMID40450051
PMCPMC12126510

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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.