Evidence map›Paper›PMID 39668159›Full record

Trial reportSignal transduction and targeted therapy2024

Clinical and biomarker analyses of SHR-1701 combined with famitinib in patients with previously treated advanced biliary tract cancer or pancreatic ductal adenocarcinoma: a phase II trial.

Lixia Yi, Haoqi Pan, Zhouyu Ning, Litao Xu, Hena Zhang, Longfei Peng, Yaowu Liu, Yifan Yang, Waimei Si, Ying Wang and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Cytokines and cancer-associated fibroblasts.Journal of hematology & oncology · 2026
    Review
  6. Strategies to target PD-1/PD-L1 in the tumor microenvironment.Cellular oncology (Dordrecht, Netherlands) · 2026
    Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Bispecific Antibodies in Solid Tumors: Advances and Challenges.International journal of molecular sciences · 2025
    Review
  13. Review
  14. 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.

Lixia Yi *Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID 0000-0001-7642-3139
Haoqi Pan *Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Zhouyu NingDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Litao XuDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Hena ZhangDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Longfei PengSuzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, China.
Yaowu LiuDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Yifan YangDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Waimei SiDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ying WangClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Xiaoyan ZhuDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Shenglin HuangDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. slhuang@fudan.edu.cn.
Zhiqiang MengDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. mengshca@fudan.edu.cn.
Jing XieDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. isable624@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advanced biliary tract cancer (BTC) and pancreatic ductal adenocarcinoma (PDAC) have poor prognoses and limited treatment options. Here, we conducted this first-in-class phase II study to evaluate the efficacy and safety of SHR-1701, a bifunctional fusion protein targeting programmed death-ligand 1 (PD-L1) and transforming growth factor-beta (TGF-β), combined with famitinib, a multi-targeted receptor tyrosine kinase inhibitor, in patients with advanced BTC or PDAC who failed previous standard treatment (trial registration: ChiCTR2000037927). Among 51 enrolled patients, the BTC cohort showed an objective response rate (ORR) of 28% (including 2 complete responses) and a disease control rate (DCR) of 80%, with a median progression-free survival (mPFS) of 5.1 months and a median overall survival (mOS) of 16.0 months. In the PDAC cohort, the ORR was 15% (2 complete responses), with a DCR of 60%, and the mPFS and mOS were 2.1 months and 5.3 months, respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 29.4% of patients, with no grade 5 TRAEs reported. Exploratory analyses revealed that primary tumor resection history, peripheral blood immunophenotype changes, and distinct immune-metabolic profiles were associated with treatment benefits. An immune/metabolism score integrating the features of six genes was developed as a predictive biomarker for immunotherapy response in multiple cohorts, allowing for the selection of patients most likely to experience positive outcomes from this therapy regimen. In conclusion, our study provides proof-of-concept data supporting the potential of SHR-1701 plus famitinib as an effective and safe subsequent-line therapy for refractory BTC and PDAC, highlighting the promise of targeting PD-L1, TGF-β, and angiogenesis pathways simultaneously.

Indexed as

Biliary Tract NeoplasmsBiomarkers, TumorCarcinoma, Pancreatic DuctalAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenFemaleHumansIndolesMaleMiddle AgedPancreatic NeoplasmsPyrrolesAntibodies, MonoclonalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanfamitinibIndolesPyrrolesRecombinant Fusion ProteinsSHR-1701Transforming Growth Factor beta

Identifiers

PMID39668159
PMCPMC11638339

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.