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Pancreatic Ductal Adenocarcinoma, PDACNCT05168254

Clinical and Multiomics Study of First-line Chemotherapy for Advanced Pancreatic Cancer

An observational study of Pancreatic Ductal Adenocarcinoma, PDAC, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The early symptoms of pancreatic cancer are not obvious, and the early diagnosis rate is low. For most patients with pancreatic cancer,palliative chemotherapy is the only choice .At present, The guidance of NCCN guidelines on the selection of chemotherapy regimens for patients with advanced pancreatic cancer is only… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma, PDAC
How many people
50 participants
Where
1 siteChina
Study dates
1 Jan 2021to 1 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced pancreatic ductal adenocarcinoma

Who may be able to join

  • Age > 18 years old, male or female;
  • Locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed by histopathology / cytology of the primary and / or metastatic lesions and not suitable for surgical resection, and don't receive chemotherapy;
  • According to the evaluation criteria of solid tumor efficacy(RECIST 1.1), there should be at least one measurable lesion (non nodular lesion with the longest diameter of 210 mm, or nodular lesion with the shortest diameter of more than 15 mm);
  • Patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up.

Who cannot join

  • If any of the following criteria is met, the patient should be excluded:
  • Pancreatic ductal adenocarcinoma is diagnosed without histopathology / cytology;
  • The target lesion has received local non-drug therapy (including radiotherapy, physical and / or chemical ablation, etc.), and there is no imaging progression;
  • If the central nervous system metastasis is known, MRI should be performed to exclude it.

Trial locations and contacts

1 site in 1 country.

Yao Zhang contact

18019076695

zyrjxh97@sjtu.edu.cn

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200433

    Yao Zhang, M.D., +86-18019076695, zyrjxh97@sjtu.edu.cn

    Duowu Zou, M.D., +86-13901617608, zdw12125@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical and Multiomics Study of First-line Chemotherapy for Advanced Pancreatic Cancer：a Prospective Single-center Research Trial

The early symptoms of pancreatic cancer are not obvious, and the early diagnosis rate is low. For most patients with pancreatic cancer,palliative chemotherapy is the only choice .At present, The guidance of NCCN guidelines on the selection of chemotherapy regimens for patients with advanced pancreatic cancer is only based on the physical condition(the ECOG score), which is one of the important reasons for the poor efficacy of chemotherapy in patients with advanced pancreatic cancer.Therefore, it is urgent to group pancreatic cancer patients according to tumor molecular typing and heterogeneity of response to chemotherapy drugs accurately,so as to guide the personalized treatment of patients.

Read the detailed description

Based on the limitations of existing studies and the needs of clinical patients, the investigators chose two time points: after the diagnosis of pancreatic cancer (before the first-line chemotherapy), and after chemotherapy evaluation in this study, to obtain in situ samples of pancreatic cancer tissues by EUS-FNA.The samples are detected by dynamic multi-omics study before and after treatment(including genomics, transcriptomics, proteomics, metagenomics, etc.).Combined with the drug reaction and clinical outcome of patients, a comprehensive model is established to predict the clinical outcome of patients with PDAC and the choice of chemotherapy regimens, so as to screen the pancreatic cancer patients who are most likely to benefit from different chemotherapy regimens, and lay the foundation for the development of individual chemotherapy for advanced pancreatic cancer.

Medical subject headings
Anophthalmia with pulmonary hypoplasia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of using the model to predict the therapeutic effect of drugs

    The difference of progression free survival (PFS)

    Measured: 1.5 years

Secondary outcomes (2)

  1. Efficacy evaluation of solid tumor

    disease control rate (DCR)

    Measured: 1.5 years

  2. the quality of participants'life

    According to the European Organization for research and treatment of cancer (EORTC) quality of life core scale EORTC QLQ-C30 (V3.0 Chinese version)，evaluating the quality of life (QOL)

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168254
Sponsor's protocol ID
RuijinH20201123
Status last verified
Dec 2021
First submitted
13 Nov 2021
Last updated
23 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Du Y, Wang J, Wang D, Li J, Zhang J, Zhao Y, Sun S, Sun H, Qi J, Bao R, Shao C, Zhang M, He X, Zhang L, Zhou C, Wang D, Su B, Zou D, Ye Y. Single-Cell Analysis of Chemotherapy-induced Remodeling Reveals CD276-driven Basal-like Chemoresistance in Pancreatic Cancer. Gastroenterology. 2026 Apr;170(4):769-786. doi: 10.1053/j.gastro.2025.09.043. Epub 2026 Feb 17.

    PubMed 41701125

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Ductal Adenocarcinoma, PDAC, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yao Zhang (18019076695, zyrjxh97@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of using the model to predict the therapeutic effect of drugs (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.

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