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

NCT05168254 | Unknown

• 1 other identifier: RuijinH20201123
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatic Ductal Adenocarcinoma, PDAC

Outcome Measures

Primary Outcomes (1)

• Accuracy of using the model to predict the therapeutic effect of drugs

  The difference of progression free survival (PFS)

  1.5 years

Secondary Outcomes (2)

• Efficacy evaluation of solid tumor

  1.5 years

• the quality of participants'life

  1.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced pancreatic ductal adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

in situ tissue samples of pancreatic cancer by EUS-FNAare immediately sent to the laboratory for sequencing. Serum, plasma and peripheral blood mononuclear cells (PBMC) are isolated from peripheral blood samples; Serum and plasma are stored in - 80 ℃ refrigerator, and PBMC are stored in liquid nitrogen. Biological samples of all patients are kept in a regulated biological sample bank.

MeSH Terms

Conditions

Anophthalmia with pulmonary hypoplasia

Study Officials

• Duowu Zou

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Zhang

CONTACT

18019076695; zyrjxh97@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: December 23, 2021
• Study Start: January 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

CN (1)