Evidence map›Paper›PMID 39102756›Full record

Trial reportThe oncologist2024

Efficacy and safety of camrelizumab, apatinib, and capecitabine combination therapy in advanced biliary tract cancer: a phase 2, nonrandomized, prospective study.

Chao Jing, Zhigang Bai, Kuinan Tong, Xiaobao Yang, Kun Liu, Hongwei Wu, Jiegao Zhu, Wei Guo, Zhongtao Zhang, Wei Deng

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04720131 (Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Biliary Tract Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04720131 phase2completednot on this map

Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Biliary Tract Cancer: a Phase 2, Single-arm, Prospective Study.

TypeinterventionalSponsorBeijing Friendship HospitalRan2021 to 2023Enrolled28ConditionsBiliary Tract Cancer, Anti-PD-1 Therapy, Targeted Molecular Therapy, CapecitabineArmsCamrelizumab, apatinib, Capecitabine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Chao JingDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.ORCID 0000-0002-2146-3448
Zhigang BaiDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Kuinan TongDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Xiaobao YangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Kun LiuDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Hongwei WuDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Jiegao ZhuDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Wei GuoDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Zhongtao ZhangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.
Wei DengDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.

Funding

Beijing Hospitals Authority Clinical Medicine Development XMLX202102National Key Technologies R&D Program 2015BAI13B09
6 · The paper itself

Abstract

backgroundBiliary tract cancer (BTC) is a highly malignant tumor, with limited therapy regimens and short response duration. In this study, we aim to assess the efficacy and safety of the combination of camrelizumab, apatinib, and capecitabine as the first- or second-line treatment in patients with advanced BTC.

methodsIn this phase 2, nonrandomized, prospective study, eligible patients received camrelizumab (200 mg, d1, Q3W), apatinib (250 mg, qd, d1-d21, Q3W), and capecitabine (1000 mg/m², bid, d1-d14, Q3W) until trial discontinued. The primary endpoint was the objective response rate (ORR). The secondary endpoints were disease control rate, progression-free survival (PFS), overall survival (OS), and safety.

resultsFrom July 2019 to April 2023, we enrolled a total of 28 patients, of whom 14 patients were in the first-line treatment setting and 14 patients were in the second-line setting. At the data cutoff (April 30, 2023), the median follow-up duration was 18.03 months. Eight of 28 patients reached objective response (ORR: 28.57%), with an ORR of 50% and 7.1% for first-line and second-line treatment patients (P = .033). The median PFS was 6.30 months and the median OS was 12.80 months. Grade 3 or 4 adverse events (AEs) occurred in 9 (32.14%) patients, including elevated transaminase, thrombocytopenia, etc. No serious treatment-related AEs or treatment-related deaths occurred.

conclusionsIn this trial, the combination of camrelizumab, apatinib, and capecitabine showed promising antitumor activity and manageable toxicity in patients with advanced BTC, especially in the first-line setting. CLINICAL

trial registrationNCT04720131.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCapecitabinePyridinesAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesAntibodies, Monoclonal, HumanizedapatinibcamrelizumabCapecitabinePyridinesbiliary tract cancerchemotherapyimmune checkpoint inhibitorsmolecular targeted therapy

Identifiers

PMID39102756
PMCPMC11546768

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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.