Evidence map›Paper›PMID 40954146›Full record

Trial reportSignal transduction and targeted therapy2025

Anlotinib plus sintilimab as first-line treatment for patients with advanced colorectal cancer (APICAL-CRC): an open-label, single-arm, phase II trial.

Zhan Wang, Bao-Dong Qin, Chen-Yang Ye, Miao-Miao Wang, Ling-Yan Yuan, Hou-Shan Yao, Xiao-Dong Jiao, Ke Liu, Wen-Li Zhou, Wen-Xing Qin and 15 more

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

Trial report in Signal transduction and targeted therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04271813 (Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer), 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.

NCT04271813 phase2completednot on this map

Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC): a Single Center, Single-arm Phase II Study (APICAL-CRC)

TypeinterventionalSponsorShanghai Changzheng HospitalRan2020 to 2024Enrolled30ConditionsColorectal Cancer, Immunotherapy, Anlotinib, SintilimabArmsAnlotinib plus Sintilimab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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

25 authors.

Zhan Wang *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.
Chen-Yang Ye *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Miao-Miao Wang *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ling-Yan Yuan *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Hou-Shan Yao *Department of General Surgery, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xiao-Dong JiaoDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ke LiuDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Wen-Li ZhouDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Wen-Xing QinDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Li SunDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Wei-Ping DaiDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Yan LingDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ying WuDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Shi-Qi ChenDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ying-Fu ZhangDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Dong-Min ShiDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xiao-Peng DuanDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xue ZhongDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xi HeDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Wen-Xin ZhaiDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Bei ZhangD Medicines Inc., Shanghai, China.
Da-Dong ZhangD Medicines Inc., Shanghai, China.ORCID 0000-0001-6419-8886
Ning GaoD Medicines Inc., Shanghai, China.
Yuan-Sheng ZangDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China. doctorzangys@163.com.

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82172710
6 · The paper itself

Abstract

This is an investigator-initiated, open-label, single-arm, phase II trial that aimed to assess the combination of sintilimab plus anlotinib among patients with treatment-naïve metastatic colorectal cancer (mCRC) (APICAL-CRC ClinicalTrials.gov number, NCT04271813). Between June 2020 and September 2023, a total of 30 patients were eventually enrolled and received the study regimen. Among these 30 patients, 50% had an Eastern Cooperative Oncology Group(ECOG) score of 0-1, and the other 50% had a score of 2. The objective response rates (ORRs) were 48.3% (95% CI 29.4-67.5) in the efficacy-evaluable cohort and 46.7% (95% CI 28.3-65.7) in the intent-to-treat (ITT) cohort. Twelve patients had stable disease, and the disease control rates (DCRs) were 89.7% (95% CI 72.6-97.8) and 86.7% (95% CI 69.3-96.2) in the efficacy-evaluable and ITT cohorts, respectively. The median progression-free survival (mPFS) was 8.6 months (95% CI 4.8-11.0), and the median overall survival (mOS) reached 22.9 months (95% CI 13.5-36.3). Treatment-related adverse events (TRAEs) of any grade were reported in 23 patients (76.7%), and grade 3 TRAEs occurred in 4 patients (13.3%). Multivariate Cox regression analysis revealed that the presence of liver metastases was an independent prognostic factor for poor PFS (HR = 5.66, 95% CI 1.58-20.2) and OS (HR = 7.85, 95% CI 1.38-44.8), whereas FLT mutation was independently associated with poor OS(HR = 12.5, 95% CI 1.54-101). This trial demonstrated that sintilimab plus anlotinib exhibited promising antitumor efficacy along with a manageable safety profile among treatment-naïve mCRC patients.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsIndolesQuinolinesAdultAgedFemaleHumansMaleMiddle AgedanlotinibAntibodies, Monoclonal, HumanizedIndolesQuinolinessintilimab

Identifiers

PMID40954146
PMCPMC12436658

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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.