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Metastatic Pancreatic Ductal AdenocarcinomaPhase 3NCT07445295

Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 3 study testing Chiauranib, Toripalimab Injection and Albumin-paclitaxel Injection in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Chiauranib, Toripalimab Injection and Albumin-paclitaxel Injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
1 siteChina
Study dates
31 Mar 2026to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Understand and voluntarily sign the written informed consent form.
  • Age 18-75 years on the day of signing the informed consent form, male or female.
  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  • No prior systemic therapy for metastatic pancreatic ductal adenocarcinoma. Participants who have received prior induction chemotherapy, concurrent radiotherapy, or adjuvant/neoadjuvant chemotherapy with curative intent, the interval of recurrence or metastasis must be at least 6 months after the last treatment.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Previously received local therapy lesion can be considered as measurable lesion unless imaging-confirmed progression.
  • ECOG Performance Status 0 or 1.
  • Life expectancy≥3 months.
  • Major organ functions meet the following criteria(no blood transfusions, hematopoietic growth factors, albumin and other medications considered by the investigator to be corrective therapy within 14 days prior to examination, except for iron supplements): Hematology: hemoglobin≥90g/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets≥100×10^9/L. Biochemistry: serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, AST/ALT≤2.5×ULN (≤5×ULN for patients with hepatic metastasis). Coagulation profile: INR < 1.5×ULN(for participants undergoing prophylactic anticoagulation therapy, investigators should determine whether the INR is within a safe and effective therapeutic range).

Who cannot join

  • Histological or cytological confirmed other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreablastoma, etc.
  • During screening, tumor invades major vessels (e.g., pulmonary artery, superior vena cava, or inferior vena cava) and significant risk of hemorrhage judged by the investigator; or known history of aneurysm.
  • Presence of active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease during the screening period. However, enrolment is permitted for subjects who meet the following requirements and have measurable lesion outside the CNS: asymptomatic after treatment and stable on imaging for at least 28 days prior to the first dose (e.g., no new or enlarging brain metastases) and have been off systemic glucocorticosteroids and anticonvulsant medications for at least 14 days prior to the first dose.
  • Presence of clinically symptomatic pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time/month) during the screening period.
  • Previous received Aurora kinase inhibitors, or systemic treatment of VEGF/VEGFR inhibitors such as bevacizumab, sorafenib, sunitinib, amlotinib, apatinib, and endostar, or immunotherapy drugs of PD-1, PD-L1, CTLA-4 inhibitors, etc.
  • Previous radiation therapy, chemotherapy, immunotherapy, targeted therapy within 28 days prior to the first dose. Chinese patent medicine witn anti-malignancy effect approved by National Medical Products Administration within 14 days prior to the first dose.
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  • Adverse effects of prior antineoplastic therapy that have not returned to ≤grade 1 of CTCAE v5.0 criteria (except for alopecia without safety risk judged by the investigator and laboratory tests specified in Inclusion Criterion 8).
  • Presence of peripheral neuropathy of CTCAE v5.0 criteria, Grade 2 or higher.
  • Major surgery (craniotomy, thoracotomy, or laparotomy) or serious unhealed wounds, ulcers, or fractures within 28 days prior to the first dose. Needle biopsy or other minor surgery (except for intravenous infusion) within 7 days prior to the first dose.
  • Significant arterial/venous thrombotic events within 6 months prior to first dose, such as deep vein thrombosis and pulmonary embolism. Superficial vein thrombosis without safety risk judged by the investigator is permitted.
  • Cardiac dysfunction or clinically meaningful cardiovascular disease, including: (1)New York Heart Association (NYHA) grade III~IV congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) <50% at screening. (2)Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy). (3)Clinically significant history of prolonged QTc interval, or QTcF interval >470ms for females or >450 ms for males during the screening period. (4)Coronary heart disease with symptoms requiring medication. (5)Documentation of hypertension treatment with≥3 antihypertensive medications simultaneously within 14 days before the first dose of medication or systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg during the screening period (resting state, measured approximately every 5 minutes, averaged after three consecutive measurements, rounded to the nearest integer). (6)History of hypertensive crisis or hypertensive encephalopathy. (7)Other cardiovascular disease judged by the investigator to be unsuitable for enrolment.
  • Active bleeding within 2 months prior to the first dose, or taking anticoagulants, such as warfarin, phenprocoumon (prophylactic low-dose aspirin and low-molecular heparin are permitted) during the screening period, or at high risk of bleeding judged by the investigator during screening period (e.g., esophageal varix associated with bleeding risk, locally active ulcer lesions, positive fecal occult blood that can not exclude gastrointestinal bleeding, intermittent haemoptysis) .
  • Presence of significant gastrointestinal abnormalities during the screening period that may interfere with drug intake, transit or absorption (e.g. inability to swallow, chronic diarrhoea, post-small bowel resection or total gastrectomy), according to the investigator's judgment.
  • History of gastrointestinal perforation and/or fistula, peptic ulcer disease, intestinal obstruction (including incomplete intestinal obstruction that requires parenteral nutrition), or biliary obstruction within 6 months prior to the first dose.
  • History of other malignant tumors within 3 years prior to the first dose, except for those treated with expected curative outcomes, such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer, and papillary thyroid microcarcinoma.
  • For urine protein≥2+ by urinalysis during the screening period, a 24-hour urine protein quantification test should be performed. The subject cannot be enrolled if the quantified urine protein is≥1g/24h. If the quantified urine protein is <1g/24h, the subject can still be enrolled.
  • Known severe hypersensitivity to any monoclonal antibody. Known hypersensitivity to Chiauranib capsules or any of its components. Known contraindications to albumin-paclitaxel and gemcitabine chemotherapy (refer to descriptions for albumin-paclitaxel and gemcitabine).
  • Presence of active tuberculosis during the screening period. Suspected subjects should be excluded by a combination of chest imaging, sputum, and through clinical signs and symptoms.
  • Presence of active hepatitis, positive HBsAg or positive HBcAb must undergo further HBV-DNA testing, enrollment is permitted only if the results meet either of the following criteria: within the normal range of the investigational site or <200 IU/mL. Positive HCV-Ab with positive viral replication. Positive of HIV. Active syphilis infection (syphilis-specific antibody and nonspecific antibody positive). (Note: Priority for qualitative detection and quantitative detection of viral replication when needed).
  • Previous or screening chest imaging showing the presence of interstitial lung disease or pulmonary fibrosis or non-infectious pneumonitis requiring treatment.
  • Active infection during the screening period, including systemic anti-infective therapy requiring oral or intravenous infusion within 2 weeks prior to the first dose, unexplained fever (≥38°C) during the screening period.
  • Screening period or history of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.
  • Unexplained weight loss of 5% or more between signing the ICF and the first dose.
  • NRS pain score ≥4 after analgesic medication during the screening period.
  • Severe central nervous system or psychiatric illness during the screening period.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: vitiligo, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, celiac disease controlled by diet alone, type I diabetes with good glycaemic control.
  • Received corticosteroid medication within 14 days before the first dose(exceed 10 mg/day of prednisone or its equivalent) or other immunosuppressive drugs. The following are exceptions to this criterion: intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), corticosteroids as prophylaxis for allergic reactions (e.g. before imaging or chemotherapy), adrenal steroid replacement(not to exceed 10 mg/day of prednisone or its equivalent).
  • Administration of a live attenuated vaccine within 28 days prior to the first dose. Live vaccines include but are not limited to: measles, epidemic parotitis, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever vaccines. Injectable inactivated seasonal influenza vaccines are allowed, but intranasal live attenuated influenza, vaccines are not allowed.
  • Pregnant or lactating females. Female participants of childbearing potential or male subjects whose partners of childbearing potential are unable or unwilling to use effective contraception (e.g., IUDs, subcutaneous implant, sterilisation, long-acting contraceptive injections, compound of short-acting oral contraceptives, etc.) from 7 days prior to the first dose until 6 months after the end of treatment. Female participants of childbearing potential must have a blood pregnancy test negative within 7days prior to the first dose. Note: Females with fertility include those who have experienced menarche and have not undergone successful artificial sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not reached menopause.
  • During the screening period, the investigator deems other conditions unsuitable for participation in this trial, such as clinically unacceptable worsening symptoms or signs of pancreatic cancer progression, comorbidities, concurrent treatments, or any laboratory abnormalities that may interfere with the assessment of efficacy and safety outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuelian Zhou contact

028-64907337

zhouxuelian@chipscreen.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xianjun Yu, 021-64175590, yuxianjun@fudanpci.org

Other trials in China

About this study

Official title: A Phase III Study of Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. The Run-in period is a single-arm, open-label study enrolling approximately 20 participants, who received the combination therapy of chiauranib plus toripalimab, albumin-paclitaxel and gemcitabine. The Randomized controlled period is a randomized, double-blind, parallel-controlled study enrolling approximately 538 participants, who are 1:1 randomly assigned to the experimental arm(chiauranib plus Toripalimab, albumin-paclitaxel and gemcitabine) or the control arm (Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabine).

Being tested
Chiauranib, Toripalimab Injection, Albumin-paclitaxel Injection, Gemcitabine Injection, Chiauranib placebo

What participants receive

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

  • ChiauranibDrug

    50 mg, oral administration once daily

  • Toripalimab InjectionDrug

    3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle

  • Albumin-paclitaxel InjectionDrug

    125 mg/m^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle

  • Gemcitabine InjectionDrug

    1000 mg/m^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle

  • Chiauranib placeboDrug

    50 mg, oral administration once daily

  • Toripalimab Injection placeboDrug

    3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle

Study groups in NCT07445295
Study groupRoleWhat they receive
Chiauranib plus toripalimab, albumin-paclitaxel and gemcitabineExperimentalNot described
Receives: Drug: Chiauranib; Drug: Toripalimab Injection; Drug: Albumin-paclitaxel Injection; Drug: Gemcitabine Injection
Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabinePlacebo comparatorNot described
Receives: Drug: Albumin-paclitaxel Injection; Drug: Gemcitabine Injection; Drug: Chiauranib placebo; Drug: Toripalimab Injection placebo

What is being measured

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

  1. Incidence and severity of adverse events

    Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0)

    Measured: Run-in period.From the enrollment until 28 days after the last dose

  2. OS

    Overall survival

    Measured: Randomized controlled period. From the first dose to death or end of study, an average of 2 year

Secondary outcomes (11)

  1. ORR

    Objective Response Rate

    Measured: Run-in period and Randomized controlled period. From the first dose to disease progression or end of study, an average of 2 year

  2. DoR

    Duration of Response

    Measured: Run-in period and Randomized controlled period. From the first dose to disease progression or end of study, an average of 2 year

  3. DCR

    Disease control rate

    Measured: Run-in period and Randomized controlled period. From the first dose to disease progression or end of study, an average of 2 year

  4. PFS

    Progression free survival

    Measured: Run-in period and Randomized controlled period. From the first dose to disease progression or end of study, an average of 2 year

  5. OS

    Overall survival

    Measured: Run-in period. From the first dose to death or end of study, an average of 2 year

  6. TTR

    Time to Response

    Measured: Randomized controlled period. From the first dose to disease progression or end of study, an average of 2 year

  7. Incidence and severity of adverse events

    Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0)

    Measured: Randomized controlled period. From the enrollment until 28 days after the last dose

  8. QoL

    Quality of Life assessed by EORTC Quality of Life Questionnaire-Pancreatic Cancer Module 26 (EORTC QLQ-PAN26). The scale consists of 26 items, covering 14 dimensions including pain, indigestion, and satisfaction with healthcare, with scores ranging from 0 to 100. For symptom dimensions, higher scores indicate more severe symptoms; for functional/psychological dimensions, higher scores reflect better functioning or greater satisfaction.

    Measured: Randomized controlled period. From the first dose to disease progression or end of study, an average of 2year

  9. Time to maximum concentration (Tmax)

    PK Profile

    Measured: Run-in period and Randomized controlled period. From the first dose to end of chiauranib treatment, an average of 2year

  10. Maximum plasma concentration (Cmax)

    PK Profile

    Measured: Run-in period and Randomized controlled period. From the first dose to end of chiauranib treatment, an average of 2year

  11. Area under the plasma concentration-time curve (AUC)

    PK Profile

    Measured: Run-in period and Randomized controlled period. From the first dose to end of chiauranib treatment, an average of 2year

Timeline

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

  1. First posted3 Mar 2026
  2. Study start31 Mar 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Nov 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07445295
Sponsor's protocol ID
CAR304
Status last verified
Feb 2026
First submitted
25 Feb 2026
Last updated
3 Mar 2026
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 3 study testing Chiauranib, Toripalimab Injection and Albumin-paclitaxel Injection in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Chipscreen Biosciences, Ltd. 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 8 inclusion and 30 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Xuelian Zhou (028-64907337, zhouxuelian@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (time frame: Run-in period.From the enrollment until 28 days after the last dose). 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 NCT07445295.

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 3 Mar 2026.

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