Evidence map›Paper›PMID 37550655›Full record

ArticleBMC cancer2023

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial).

Nan Zhou, Xiaofen Li, Yu Yang, Sirui Tan, Shunyu Zhang, Qiyue Huang, Hongfeng Gou

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2023. 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
1.0field-weighted citation impact, top 24% of its field
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, 3 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

7 authors at 1 institution in 1 country.

Nan Zhou *Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Xiaofen Li *Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Yu YangDepartment of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Sirui TanDepartment of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Shunyu ZhangDepartment of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Qiyue HuangDepartment of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China.
Hongfeng GouDepartment of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No.37 Guo Xue Xiang, 610041, Chengdu, Sichuan, China. gouhongfeng1977@wchscu.cn.ORCID http://orcid.org/0000-0002-2071-6773
Sichuan University · CN

Funding

the Health Commission of Sichuan Province Program 21PJ007
6 · The paper itself

Abstract

backgroundBiliary tract cancer (BTC) is a relatively rare but highly aggressive malignancy. However, there is currently no satisfactory second-line regimen for patients without specific genetic mutations. Nanoparticle albumin-bound paclitaxel, also known as nab-paclitaxel (Abraxane, Bristol Myers Squibb), has shown activity in patients with BTC. Studies investigating the immunogenic features of BTC suggested that checkpoint inhibition may lead to antitumor immune responses. In recent years, improved survival has been observed in patients treated with chemotherapy combined with immunotherapy across multiple cancer types, including BTC. This clinical trial aims to evaluate the efficacy and safety of second-line sintilimab in combination with nab-paclitaxel in advanced BTC patients.

methodsThe NapaSinti trial is a prospective, nonrandomized, open-label, phase 2 study conducted at a tertiary hospital in Chengdu, China. Eligible patients are those with histologically or cytologically confirmed locally advanced non-resectable or metastatic adenocarcinoma in the biliary tract (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), aged between 18 and 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who have experienced disease progression after prior gemcitabine- or fluorouracil-based chemotherapy and have not received taxane or immune checkpoint inhibitor treatment. Enrolled patients will receive intravenous administration of sintilimab 200 mg on day 1 and nab-paclitaxel 125 mg/m2 on days 1 and 8, every three weeks. The primary endpoint is the objective response rate (ORR), while the secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety. Exploratory objectives aim to identify biomarkers and molecular signatures for predicting response or prognosis. Using Simon's two-stage design, a total of 63 participants will be enrolled in the study. This trial was initiated in March 2022 in China. DISCUSSION: The NapaSinti trial evaluates the efficacy and safety of second-line sintilimab plus nab-paclitaxel for advanced biliary tract cancer. Additionally, the trial provides an opportunity for translational research.

trial registrationChinese Clinical Trial Registry ChiCTR2100052118. Registered October 19, 2021.

Indexed as

Bile Duct NeoplasmsBiliary Tract NeoplasmsCholangiocarcinomaAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBile Ducts, IntrahepaticClinical Trials, Phase II as TopicDeoxycytidineHumansMiddle AgedPaclitaxelProspective Studies130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedDeoxycytidinePaclitaxelsintilimabanti-PD-1 antibodyBiliary tract cancerChemotherapyImmunotherapyNanoparticle albumin-bound (nab)-paclitaxelPhase 2 studySecond lineSintilimab

Identifiers

PMID37550655
PMCPMC10405505
OpenAlexW4385633945

What OpenQuestion holds

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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.