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Pancreatic Adenocarcinoma MetastaticPhase 2NCT06396637

PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

A Phase 2 study testing Sapropterin Dihydrochloride in people with Pancreatic Adenocarcinoma Metastatic, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Adenocarcinoma Metastatic
What is being tested?
Sapropterin Dihydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
30 Apr 2024to 30 Apr 2025
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
  • Recurrent disease or metastatic disease evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
  • Fail or could not tolerate standard chemotherapy.
  • ECOG score 0 or 1.
  • Have measurable target lesion.
  • Serum total bilirubin level is less than 1.5 x ULN. ALT and AST are less than 2 x ULN. Hemoglobin≥9g/dL, platelet≥75×10*9/L, white blood count ≥3.0×10*9/L, neutrophil ≥1.5×10*9/L. Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate > 60 mL/min.
  • Signed informed consent.

Who cannot join

  • History of participation of other clinical trials within 4 weeks
  • Known or suspected allergy to Sintilimab or tetrahydrobiopterin.
  • Female patients during pregnancy or lactation.
  • Patients who lack the ability to provide informed consent due to psychological, family, social, or other factors.
  • Patients with a history of other malignant tumors besides pancreatic cancer before enrollment, except for non-melanoma skin cancer, carcinoma in situ of the cervix, or cured early-stage prostate cancer.
  • Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that are intolerable to radiotherapy, chemotherapy, or surgery.
Show all 11Show fewer
  • Patients with autoimmune diseases, a history of autoimmune diseases (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), as well as a history of immune deficiency, including HIV-positive test results, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation.
  • Patients who require systemic corticosteroid therapy (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the first administration or during the study. However, the following situations are allowed for enrollment: In the absence of active autoimmune diseases, patients are allowed to use topical or inhaled steroids, or adrenal hormone replacement therapy at a dose ≤ 10 mg/day prednisone equivalent dose.
  • Patients with a history of interstitial lung disease or non-infectious pneumonia.
  • Patients with active pulmonary tuberculosis infection detected through medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without proper treatment.
  • Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10*4 copies/mL), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method).

Trial locations and contacts

1 site in 1 country.

Miao-Zhen Qiu, MD contact

02087343351

qiumzh@sysucc.org.cn

China1 site, 1 recruiting

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Miao-zhen Qiu, MD

    Rui-hua Xu, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment.

The prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. However, research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies. In this context, researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment.

Read the detailed description

There is no standard treatment for patients with metastatic pancreatic cancer who failed to FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane). Patients with metastatic pancreatic cancer who are unable to tolerate or have failed to respond to standard chemotherapy will be enrolled in this clinical trial. They will be administered a combination treatment of Sapropterin Dihydrochloride and PD-1 antibody. The primary endpoints of this study are objective response rate and safety. The secondary endpoints will encompass overall survival, progression-free survival, and quality of life. The study aims to enroll a total of 20 participants.

Being tested
Sapropterin Dihydrochloride
Keywords
Pancreatic adenocarcinoma, PD-1 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sapropterin DihydrochlorideDrug

    Also called PD-1 Antibody

    Sapropterin Dihydrochloride: 20mg/kg, qd

Study groups in NCT06396637
Study groupRoleWhat they receive
Treatment armExperimentalPD-1 Antibody combined with Sapropterin Dihydrochloride
Receives: Drug: Sapropterin Dihydrochloride

What is being measured

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

  1. Objective response rate

    The percentage of patients whose cancer shrinks or disappears after treatment

    Measured: Every 6 weeks (2 cycles) from first treatment to disease progression or totally 2 years Based on irRECIST

  2. Adverse events by NCI-CTCAE v5.0

    Safety and tolerability

    Measured: Every 3 weeks from first treatment to disease progression or totally 2 years Based on irRECIST

Secondary outcomes (4)

  1. Overall Survival (OS)

    The time from registration to death due to any cause, or censored at date last known alive.

    Measured: up to approximately 2 year

  2. Progression-Free Survival (PFS)

    PFS as measured in accordance with the irRECIST version 1.1

    Measured: up to approximately 1 year

  3. EORTC QLQ-C30 survey

    Quality of life survey

    Measured: up to approximately 2 year

  4. EORTC-QLQ-PAN26 survey

    Quality of life survey

    Measured: up to approximately 2 year

Timeline

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

  1. First posted2 May 2024
  2. Study start30 Apr 2024
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
PD-1 Antibody combined with Sapropterin Dihydrochloride
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06396637
Sponsor's protocol ID
SYSUCC-PDAC
Status last verified
Apr 2024
First submitted
30 Apr 2024
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sapropterin Dihydrochloride in people with Pancreatic Adenocarcinoma Metastatic, run by Sun Yat-sen University 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 7 inclusion and 11 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 2 May 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Miao-Zhen Qiu, MD (02087343351, qiumzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Every 6 weeks (2 cycles) from first treatment to disease progression or totally 2 years Based on irRECIST). The study lists 2 primary outcomes in all. 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 NCT06396637.

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 2 May 2024.

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