Evidence map›Paper›PMID 41121202›Full record

Trial reportBMC medicine2025

Anti-PD1 antibody toripalimab combined with lenvatinib, or GEMOX chemotherapy combined with lenvatinib as first-line therapy in patients with advanced intrahepatic cholangiocarcinoma: a randomized, open, two-cohort Phase 2 Study.

Xiao-Yong Huang, Guo-Ming Shi, Zhi-Tao Zheng, Hui-Chuan Sun, Fei Liang, Yuan Ji, Yi Chen, Guo-Huan Yang, Zhi-Qiang Hu, Jia-Cheng Lu and 5 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT04361331 phase2completednot on this map

A Randomized, Open, Two-cohort Phase 2 Study of Toripalimab(PD1) Combined With Lenvatnib, or Gemox Chemotherapy Combined With Lenvatinib as First-line Therapy in Patients With Advanced or Unresectable Intrahepatic Cholangiocarcinoma

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2020 to 2023Enrolled61ConditionsCholangiocarcinoma, IntrahepaticArmsLenvatinib combined with gemox, Toripalimab combined with lenvatinib
NCT07636798 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib/II, Single-arm Clinical Study

TypeinterventionalSponsorWest China HospitalRan2026 to 2029Enrolled20ConditionsBiliary Tract CancerArmsHAIC Combined Regimen Treatment Group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Advances in Immunotherapy for Intrahepatic Cholangiocarcinoma.International journal of molecular sciences · 2026
    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

15 authors.

Xiao-Yong Huang *Department of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Guo-Ming Shi *Department of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Zhi-Tao Zheng *Department of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Hui-Chuan SunDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Fei LiangDepartment of Statistics, Zhongshan Hospital, Fudan University, Shanghai, China.
Yuan JiDepartment of Pathology, Zhongshan Hospital, Fudan University, Shanghai, China.
Yi ChenDepartment of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
Guo-Huan YangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Zhi-Qiang HuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Jia-Cheng LuDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Xian-Long MengDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Xiao-Jun GuoDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Chao-Chen ZhangDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Jia FanDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China.
Jian ZhouDepartment of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai, 200032, China. zhou.jian@zs-hospital.sh.cn.

Funding

National Natural Science Foundation of China 81830102National Natural Science Foundation of China 81972232National Natural Science Foundation of China 82273234Shanghai Municipal Key Clinical Specialty Construction Project shslczdzk02401Shanghai Municipal Natural Science Foundation 21ZR1412200
6 · The paper itself

Abstract

backgroundThis research aimed to assess the efficacy and safety of a regimen combining lenvatinib with an anti-PD-1 antibody or chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC).

methodsA two-arm, open-label, phase II trial was carried out. Participants in Arm A received 240 mg of toripalimab intravenously on day 1 of each 3-week cycle, plus daily oral lenvatinib at 8 mg (< 60 kg) or 12 mg (≥60 kg). Participants in Arm B were administered the same daily lenvatinib in combination with GEMOX chemotherapy: 85 mg/m

resultsSixty one patients were recruited, with 31 in Arm A and 30 in Arm B. The ORR of Arm A was 32.3% (10/31; 95% CI: 16.7%-51.4%), and three patients underwent surgery after tumor downstaging. The median OS was 20.3 months (95% CI: 9.3-27.1), and median PFS was 8.9 months (95% CI: 4.2-13.9). Arm B showed an ORR of 40.0% (12/30; 95% CI: 22.7%-59.4%), and one patient proceeded to surgery after downstaging. Median OS was 15.5 months (95% CI: 9.6-23.8), and median PFS was 8.0 months (95% CI: 5.0-11.4). Adverse events (AEs) related to treatment were observed in most patients, with grade 3-4 AEs in 35.5% of Arm A and 40.0% of Arm B. The most frequent AEs were fatigue (71% vs. 63%), paresthesia (45% vs. 40%), and gingivitis (45% vs. 20%). Grade 4 thrombocytopenia occurred in 6.7% of Arm B. No grade 5 AEs were observed. Peripheral blood analysis showed monocyte levels decreased in PR(partial  response) patients in Arm A but increased in PR patients in Arm B.

conclusionsThe Combination of lenvatinib with either anti-PD-1 antibody or GEMOX chemotherapy is a well-tolerated and effective treatment for advanced ICC. TRAIL REGISTRATION: ClinicalTrials.gov, NCT04361331.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBile Duct NeoplasmsCholangiocarcinomaDeoxycytidinePhenylurea CompoundsQuinolinesAdultAgedFemaleGemcitabineHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinAntibodies, Monoclonal, HumanizedDeoxycytidineGemcitabinelenvatinibOrganoplatinum CompoundsOxaliplatinPhenylurea CompoundsQuinolinestoripalimabAnti-PD-1 antibodyGEMOX chemotherapyIntrahepatic cholangiocarcinomaLenvatinib

Identifiers

PMID41121202
PMCPMC12539035

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.