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Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 2NCT06472037

AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC

A Phase 2 study testing Cadonilimab, Gemcitabine and Nab-Paclitaxel in people with Locally Advanced Pancreatic Ductal Adenocarcinoma, run by Tianjin Medical University Cancer Institute and 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cadonilimab, Gemcitabine and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jul 2024to 1 Jul 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

  • Patients eligible for this study must meet all of the following criteria:
  • Obtain written informed consent before implementing any trial-related procedures;
  • Age ≥ 18 years and ≤ 75 years, gender not specified;
  • Pancreatic cancer confirmed by histopathology examination;
  • Locally advanced pancreatic ductal adenocarcinoma and no prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received;
  • At least one measurable lesion on imaging according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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  • ECOG score 0-1;
  • Expected survival time >3 months;
  • Adequate organ function, subjects must meet the following laboratory criteria:
  • 1)Absolute neutrophil count (ANC) ≥1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days.
  • 2)Platelet count ≥100x10^9/L without blood transfusion in the past 14 days. 3)Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 14 days; 4)Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 5)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; 6)Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60ml/min; 7)Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8)Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be included in the study.
  • 9.For female subjects of childbearing potential, a urine or serum pregnancy test should be performed within 3 days before receiving the first dose of the study drug (Day 1 of Cycle 1) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
  • 10.All subjects, male or female, were required to use contraception with an annual failure rate of less than 1% during the entire treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic drug) if there was a risk of pregnancy.

Who cannot join

  • Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection);
  • Is currently participating in an interventional clinical study or has received other study medication or used the study device within 4 weeks prior to the first dose;
  • Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed against another stimulatory or synergistic T cell receptor suppressor (e.g., CTLA-4, OX-40, CD137);
  • Systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) within 2 weeks before the first administration;
  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy;
  • Is receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal, inhaled, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: The use of physiological doses of glucocorticoids (≤10mg/day of prednisone or equivalent) is allowed;
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  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
  • Known allergy to the investigational drug carfilzomib, gemcitabine, or any excipient of albumin-bound paclitaxel;
  • Have not fully recovered from any toxicities and/or complications due to any prior interventions before starting treatment (i.e., ≤ Grade 1 or back to baseline, excluding fatigue or alopecia);
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive);
  • Uncontrolled active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copies above the upper limit of normal for the testing laboratory at the study center);
  • Note: Subjects with the following criteria can also be included:
  • HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV treatment throughout the study drug treatment period to prevent viral reactivation
  • Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need close monitoring for viral reactivation 12.Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the detection limit); 13.Received live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Administration of inactivated influenza vaccine for seasonal flu is allowed within 30 days before the first dose, but intranasal live attenuated influenza vaccine is not allowed.
  • 14.Pregnant or lactating women; 15.Presence of any severe or uncontrolled systemic diseases, such as:
  • Resting electrocardiogram showing significant and symptomatic abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;
  • Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥2;
  • Any arterial thrombosis, embolism, or ischemia events such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to initiation of therapy;
  • Suboptimal blood pressure control (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);
  • History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to initial dosing, or current clinical active interstitial lung disease;
  • Active pulmonary tuberculosis;
  • Active or uncontrolled infections requiring systemic therapy.
  • Clinical active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction;
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
  • Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L);
  • Urinalysis shows urine protein ≥++, and confirmed 24-hour urine protein quantification >1.0g;
  • Presence of mental disorders and inability to cooperate with treatment; 16 There may be potential risks that could interfere with the trial results, hinder the full participation of subjects in the study, such as medical history or evidence of diseases, abnormal treatment or laboratory test values, or other conditions deemed unsuitable for inclusion by the researchers. Researchers may also identify other potential risks that make participation in this study unsuitable.

Trial locations and contacts

1 site in 1 country.

Rui Liu, MD contact

13602139003

liurui9003@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300052

    Rui Liu, 13602139003, ruiliu688@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-arm, Phase II Study Assessing the Efficacy of Gemcitabine, Nab-paclitaxel, and Cadonilimab With Sequential Short-course Radiotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma Patients.

A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.

Read the detailed description

This trial is a prospective, single-arm, single-center, phase II clinical study aimed at investigating the efficacy and safety of Cadonilimab combined with Gemcitabine and Nab-palitaxe in short-course radiotherapy neoadjuvant treatment for locally advanced pancreatic ductal adenocarcinoma patients. Patients will receive Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment for one cycle, followed by sequential short-course radiotherapy and then Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment. If feasible, radical surgery will be performed to assess efficacy. A total of 8 cycles of chemotherapy will be administered, followed by Cadonilimab maintenance for up to 1 year.

Being tested
Cadonilimab, Gemcitabine, Nab-Paclitaxel

What participants receive

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

  • CadonilimabDrug

    Also called AK104

    10mg/kg，IV，D1，Q3W

  • GemcitabineDrug

    Also called Gemcitabine injiection

    1000mg/m2，IV，D1、D8、D15，Q4W

  • Nab-PaclitaxelDrug

    Also called Nab-Paclitaxel-Rituximab Complex

    125mg/m2，IV，D1、D8、D15，Q4W

Study groups in NCT06472037
Study groupRoleWhat they receive
Gemcitabine and Nab-paclitaxel combined with Cadonilimab and Sequential Short-course RadiotherapyExperimentalCadonilimab 10mg/kg Q3W；Gemcitabine 1000mg/m2 Q4W；Nab-paclitaxel 125mg/m2 Q4W； Short-course Radiotherapy
Receives: Drug: Cadonilimab; Drug: Gemcitabine; Drug: Nab-Paclitaxel

What is being measured

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

  1. Clinical benefit rate (CBR, CR+PR+SD)

    Clinical benefit rate ( complete response and partial response and stable disease)

    Measured: 1 year

Secondary outcomes (6)

  1. ORR

    overall response rate

    Measured: 1 yaear

  2. PCR

    Complete pathological response rate

    Measured: 1 year

  3. (EFS)RECIST 1.1

    event free survival

    Measured: 1 year

  4. OS

    Overall survival .OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.

    Measured: 1 year

  5. Surgical conversion rate

    Surgical conversion rate

    Measured: 1 year

  6. (AEs)CTCAE 5.0

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

    Measured: 1 year

Timeline

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

  1. First posted24 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jul 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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06472037
Sponsor's protocol ID
AK104-IIT-C-N1-0122
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
4 Dec 2024
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?

A Phase 2 study testing Cadonilimab, Gemcitabine and Nab-Paclitaxel in people with Locally Advanced Pancreatic Ductal Adenocarcinoma, run by Tianjin Medical University Cancer Institute and 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 13 inclusion and 27 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 4 Dec 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 Rui Liu, MD (13602139003, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate (CBR, CR+PR+SD) (time frame: 1 year). 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 NCT06472037.

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 4 Dec 2024.

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