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Pancreatic Ductal Adenocarcinoma, PDACNCT05201729

Influence Factors of PD-1 Therapeutic Efficacy in 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 The sponsor has not verified this record for over two years, so it may be out of date.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 diagnosis rate of pancreatic cancer is low and most patients rely on palliative chemotherapy. However, the clinical benefit and objective response rate (ORR) of patients with first-line chemotherapy are low. 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
30 participants
Where
1 siteChina
Study dates
1 Aug 2021to 31 Dec 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 cancer who failed in the first-line chemotherapy

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 unsuitable for surgical resection;
  • The failure of first-line chemotherapy with gemcitabine or FOLFINOX, disease progression or intolerable severe toxicity;
  • The time from the end of the last chemotherapy should be more than 28 days;
  • 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);
  • ECOG score:0~2;
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  • Hematology, biochemistry and organ function indexes meet the following requirements:
  • The absolute count of neutrophils (ANC) is more than 1.5x10% / L
  • Platelet count (PLT) ≥ 80x109/l
  • Hemoglobin (HB) ≥ 9.0 g/dl
  • TBIL is less than 2.0 ULN, albumin (ALB) 230g / L
  • In patients without liver metastasis, alanine transaminase (ALT) and / or aspartate -transaminase (AST) are less than 3.0 ULN
  • Patients with liver metastasis, ALT and / or ASTS <5.0*ULN
  • Serum creatinine (CREA) < 1.5 x ULN, and creatinine clearance rate (CER) ≥ 30ml / min (Cockcroft-Gault);
  • Women of childbearing age receives negative pregnancy test within 14 days before treatment. Male and female patients of childbearing age and their sexual partners agree to use reliable contraceptive methods within 14 days before enrollment, during the study and within 60 days after drug withdrawal；
  • 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;
  • Patients with carcinoma of Vater's ampulla or adenocarcinoma of biliary tract;
  • Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment;
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  • Ascites increases gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
  • In the past 5 years, patients had a history of other malignant tumors, except for the following two cases: a)After other malignant tumors treated by a single operation, 5-year disease-free survival (DFS) was achieved;b)Cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
  • Pregnant or lactating women;
  • Active infection; Poorly controlled hypertension (≥ 150 / 100mmhg); Angina pectoris and unstable angina pectoris in recent 3 months, myocardial infarction, cardiac insufficiency (> NYHA class II), schizophrenia, or history of psychotropic drug abuse in 1 year before enrollment;
  • If HBV-DNA is more than 104 copies or more than 2000 IU / ml, antiviral and liver protection therapy should be carried out first. Only when HBV-DNA is less than 104 copies (2000 IU / ml), can the patients be enrolled in the group, and continue to take antiviral drugs, monitor liver function and HBV viral load; HCV antibody or HCV-RNA were positive; HIV infected patients (non high risk group, without clinical symptoms or signs indicating HIV infection, HIV test may not be carried out);
  • Any of the following treatments were given within prior to enrollment:
  • Within 4 weeks, received surgery of grade II or above (according to the operation classification catalogue (revised version in 2014) issued by the state health and Family Planning Commission); No matter whether it is related to tumor or not);
  • Received extended radiotherapy within 4 weeks or limited range radiotherapy within 2 weeks (researchers in each center can judge the appropriate time to enter the group according to the recovery of toxicity after radiotherapy);
  • Within 4 weeks or participating in other therapeutic / interventional clinical trials;
  • Received local anti-tumor therapy within 4 weeks;
  • NCI ctcae2 or above toxicity caused by previous treatment and not yet recovered (excluding hair loss and skin pigmentation);
  • It is known that PD-1 monoclonal antibody and its excipients are allergic or intolerable;
  • There are other situations that the researchers think are not suitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

Yao Zhang contact

18019076695

zyrjxh97@sjtu.edu.cn

Duowu Zou contact

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: Exploring the Influence Factors of the Efficacy of PD-1 Monoclonal Antibody Therapy in Advanced Pancreatic Cancer After Failure of First-line Chemotherapy by Using Multiomics Technology

The early diagnosis rate of pancreatic cancer is low and most patients rely on palliative chemotherapy. However, the clinical benefit and objective response rate (ORR) of patients with first-line chemotherapy are low. Therefore,it is essential to develop new therapies to improve the survival of patients with pancreatic cancer.

Read the detailed description

In this study, patients with advanced pancreatic cancer who failed in the first-line chemotherapy will be included to receive anti-PD-1 monoclonal antibody treatment, and a high-throughput study with a small sample size will be carried out by using multiomics technology to capture the heterogeneity of response to PD-1 therapy in patients with pancreatic cancer.The investigators choose two time points: after chemotherapy failure (before PD-1 therapy) and during efficacy evaluation（after PD-1 therapy）, to obtain in situ samples of pancreatic cancer tissues by EUS-FNA.The samples are tested by dynamic multi-omics studybefore and after treatment (including genomics, transcriptomics, metabonomics, proteomics, etc.).And combining the results with the drug reaction and clinical outcome of patients for a comprehensive analysis.The purpose of this study is to explore the potential biomarkers or omics of PD-1 therapy and lay the foundation for building a model to predict the effect of PD-1 therapy in patients with 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. The difference of progression free survival (PFS)

    The time from random to the first occurrence of disease progression or death from any cause.

    Measured: 1.5 years

Secondary outcomes (2)

  1. Disease control rate (DCR)

    The percentage of cases with remission and disease stability after treatment in the whole evaluable cases.

    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 posted21 Jan 2022
  2. Study start1 Aug 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201729
Sponsor's protocol ID
RJ2020368
Status last verified
Jan 2022
First submitted
10 Jan 2022
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 16 inclusion and 19 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 8 Feb 2022. 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?

The difference of progression free survival (PFS) (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 NCT05201729.

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 8 Feb 2022.

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