Evidence map›Paper›PMID 41264024›Full record

Trial reportCancer immunology, immunotherapy : CII2025

Fruquintinib plus sintilimab in previously bevacizumab-treated, pMMR/MSS refractory metastatic colorectal cancer: a phase 2 clinical trial.

Wen Zhang, Cai-Feng Gong, Jing-Long Huang, Tian-Yi Liu, Yong-Kun Sun, Zhi-Chao Jiang, Wang Qu, Lin Yang, Ying Xin, Fei-Long Zhao and 2 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

12 authors.

Wen Zhang *Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Cai-Feng Gong *Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Jing-Long HuangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Tian-Yi LiuDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Yong-Kun SunDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Zhi-Chao JiangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Wang QuDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Lin YangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Ying XinMedical Department, 3D Medicines Inc., Shanghai, 201114, China.
Fei-Long ZhaoMedical Department, 3D Medicines Inc., Shanghai, 201114, China.
Yue-Zong BaiMedical Department, 3D Medicines Inc., Shanghai, 201114, China.
Ai-Ping ZhouDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. aiping_zhou@yeah.net.

Funding

Beijing Hope Run Special Fund of Cancer Foundation of China LC2022A28Beijing Natural Science Foundation L222101CAMS Innovation Fund for Medical Sciences (CIFMS) 2021-I2M-1-066Major Project/Translational research project of Medical Oncology Key Foundation of Cancer Hospital Chinese Academy of Medical Sciences CICAMS-MOMP2022004/CICAMS-MOTRP2022005
6 · The paper itself

Abstract

backgroundThis study aimed to investigate the efficacy and safety of fruquintinib plus sintilimab in mismatch repair-proficient (pMMR)/microstatellite stable (MSS) refractory metastatic colorectal cancer (mCRC).

methodsPatients with pMMR/MSS mCRCs who had failed at least 2 lines of standard therapy were enrolled and treated with fruquintinib plus sintilimab in this single arm, phase II clinical trial. The primary endpoint was the 6 month progression-free survival (PFS) rate.

resultsA total of 75 patients were included, all of whom had been previously treated with bevacizumab. The 6 month PFS rate was 33.3%. The median PFS (mPFS) was 4.1 months, the median overall survival (mOS) was 15.3 months, the objective response rate (ORR) was 12.5%, and the disease control rate (DCR) was 76.4%. Treatment-related adverse events (TRAEs) occurred in 94.7%, with 18.7% being grade 3 or 4. There were no treatment-related deaths. Patients had a significantly shorter mPFS compared to those without liver metastasis (3.2 versus 7.6 months, P < 0.001). Incorporating Eastern Cooperative Oncology Group (ECOG) score further improved its predictive value for PFS. Those in the high-albumin group showed significantly longer mOS (25.9 versus 11.0 months, P = 0.024), while the high-neutrophil-to-lymphocyte ratio (NLR) group exhibited a significantly shorter mOS (9.3 versus 19.3 months, P = 0.033).

conclusionsFruquintinib plus sintilimab showed promising activity and good tolerability in refractory pMMR/MSS mCRC. Liver metastasis was a negative predictor for efficacy and PFS, especially when combined with the ECOG score. Higher baseline albumin and lower NLR predicted longer OS.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsQuinazolinesAdultAgedAged, 80 and overBenzofuransDNA Mismatch RepairDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedBenzofuransBevacizumabHMPL-013QuinazolinessintilimabAlbuminColorectal cancerImmune checkpoint inhibitorLiver metastasisNeutrophil-to-lymphocyte ratioTyrosine kinase inhibitor

Identifiers

PMID41264024
PMCPMC12635018

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.