Evidence map›Paper›PMID 41719193›Full record

Trial reportThe oncologist2026

Anlotinib in combination with trifluridine-tipiracil in patients with refractory metastatic colorectal cancers: a phase II, single arm study.

Qing Liu, Chi Zhang, Mengling Liu, Ke Peng, Xiaojing Xu, Yiyi Yu, Tianshu Liu

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Qing LiuCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Chi ZhangCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Mengling LiuCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Ke PengCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiaojing XuCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Yiyi YuCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.
Tianshu LiuCancer Center, Shanghai Key Laboratory of Oncology Target Discovery and Antibody Drug Development, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-8604-6311

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe management of metastatic colorectal cancer (mCRC) in late-line settings remains a significant clinical challenge. The SUNLIGHT trial, which investigated the combination of trifluridine-tipiracil (FTD-TPI) and bevacizumab, reported a median progression-free survival (PFS) of 5 months and an objective response rate (ORR) of 6.3%. This phase II study was conducted to evaluate the potential of combining anlotinib with FTD-TPI as a third-line treatment strategy in patients with refractory mCRC.

methodsIn this open-label, single-arm phase II study, mCRC patients who had experienced disease progression following at least two prior standard treatment regimens were enrolled. Participants received a combination of anlotinib (12 mg, PO, QD, days 1-14, q3w) and FTD-TPI (35 mg/m2, PO, BID, days 1-5, q2w). The primary endpoint was the ORR. Secondary endpoints included disease control rate (DCR), PFS, overall survival (OS) and safety.

resultsAs of May 30, 2025, twenty-one patients with mCRC were enrolled in this study. The median age was 62 years, with 71.4% male participants. Among the 20 evaluable patients, 2 achieved a partial response (PR), 16 had stable disease (SD) at the first evaluation. The ORR was 10.0% (2/20), and the DCR reached 90.0% (18/20). Based on Kaplan-Meier estimates, the median PFS was 5.6 months. The most common grade ≥3 treatment emergent adverse event (TEAEs) were neutropenia (25%) and thrombocytopenia (5%).

conclusionThe combination of anlotinib and FTD-TPI demonstrated promising efficacy and a manageable safety profile, supporting its potential as a favorable late-line treatment option for patients with refractory mCRC. CLINICALTRIALS.GOV IDENTIFIER: ChiCTR2400079535.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsIndolesPyrrolidinesQuinolinesThymineTrifluridineAdultAgedDrug CombinationsFemaleHumansMaleMiddle AgedNeoplasm MetastasisProgression-Free SurvivalanlotinibDrug CombinationsIndolesPyrrolidinesQuinolinesThymineTrifluridinetrifluridine tipiracil drug combinationanlotiniblate-line therapymetastatic colorectal cancertrifluridine-tipiracil

Identifiers

PMID41719193
PMCPMC12958117

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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.