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Metastatic Pancreatic CarcinomaPhase 2NCT06759090

Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate for Treatment of Advanced Pancreatic Cancer

A Phase 2 study testing Metronomic capecitabine, Camrelizumab and Apatinib Mesylate Tablets in people with Metastatic Pancreatic Carcinoma, run by Zhejiang University 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 study is a multicenter, single-arm, phase II exploratory study, aims to evaluate the efficacy and safety of metronomic capecitabine with camrelizumab and apatinib mesylate in advanced pancreatic cancer after the failure of first-line treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Carcinoma
What is being tested?
Metronomic capecitabine, Camrelizumab and Apatinib Mesylate Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
15 Jan 2025to 15 Jun 2028
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1: Age is 18 years or older; 2: Pathologically confirmed pancreatic adenocarcinoma; 3: As determined by the investigator, second-line treatment for advanced pancreatic cancer has failed; or the patient has a poor performance status (PS score >1), and the investigator considers that the patient cannot tolerate a second-line regimen with two or more drugs.
  • 4: Performance status PS score 0-2; 5: Expected survival period >= 3 months; 6: According to the RECIST1.1 criteria, the patient has at least one measurable lesion present; 7: Good organ function levels: • ANC>=1.5×10^9/L; • PLT>=75×10^9/L; • Hb>=80 g/L; • TBIL<=1.5×ULN; • ALT and AST<=3×ULN; For patients with liver metastases, ALT and AST<=5×ULN; • Cr<=1.5×ULN, if Cr>1.5×ULN, then Ccr>50ml/min (calculated by Cockcroft-Gault formula); • LVEF>=50%; • Fridericia corrected QT interval (QTcF) <450 ms for males, <470 ms for females.
  • 8: After assessment by the researcher, the participant is able to comply with the trial protocol; 9: Voluntarily participate in this clinical trial, understand the research procedures, and can sign the informed consent form in writing;

Who cannot join

  • 1: Patients who have developed resistance after treatment with capecitabine and apatinib are not recommended for enrollment unless more than 6 months have passed since the last dose, in which case they can continue to challenge its use; patients who have previously undergone immunotherapy (regardless of whether or not they used camrelizumab) can cross-line use or switch to camrelizumab to continue challenging its use.
  • 2: Received chemotherapy, radiotherapy, immunotherapy, biologics, or endocrine therapy for anti-tumor treatment, or other investigational drugs not yet on the market within 4 weeks before the first use of the study drug; 3: Within 4 weeks before the first use of the study drug, the subject has undergone major organ surgery (excluding biopsy) or experienced significant trauma, or requires elective surgery during the trial period; 4: Use of steroid hormones (prednisone equivalent) greater than 20 mg/day for more than 14 consecutive days within 14 days before the first use of the study drug; 5: Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade <=1 (excluding alopecia and other toxicities determined by the investigator to pose no safety risk).
  • 6: Past or current retinal vein occlusion (RVO) or high-risk factors (such as uncontrolled glaucoma or high intraocular pressure, history of hyper-viscous blood syndrome or hypercoagulable state); 7: History of active major bleeding; 8: Uncontrolled hypertension; 9: Severe unhealed wounds or fractures; 10: Ulcer, bowel perforation or intestinal obstruction; 11: After evaluation by researchers, there are contraindications for drug prophylaxis of thromboembolism; 12: Central nervous system metastasis, leptomeningeal metastasis; 13: Past medical history or physical examination reveals central nervous system diseases, except for those that have been adequately treated (such as primary brain tumors, uncontrolled seizures, or stroke); 14: Active viral, bacterial, or fungal infections requiring systemic treatment (such as pneumonia); 15: Has a history of active tuberculosis; 16: A history of immunodeficiency, including HIV test positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 17: Had active autoimmune diseases requiring systemic treatment within the past 2 years; 18: Vaccination within 30 days before treatment, including intranasal influenza vaccine, except for seasonal influenza vaccine; 19: Within 3 months prior to treatment, there were cardiovascular diseases, including: unstable angina; clinically significant or drug-treated malignant arrhythmias; myocardial infarction; Class III-IV heart failure; transient ischemic attack; thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.), and any other cardiac conditions deemed by the investigator as unsuitable for participation in this trial.
  • 20: Pre-cancerous blood disorders, such as myelodysplastic syndromes; 21: Clinical history of or pre-existing interstitial lung disease, such as non-infectious pneumonia or pulmonary fibrosis, or evidence of interstitial lung disease found on baseline chest CT scan; 22: Positive baseline pregnancy test in female patients who are pregnant, breastfeeding, or have childbearing potential; 23: Patients who have had other primary malignant tumors within the past 5 years, except for locally curable tumors (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ) can be enrolled after a definitive cure.
  • 24: May be allergic to any of the drug ingredients; 25: According to the investigator's judgment, there are other serious conditions that endanger patient safety or affect the patient's ability to complete the study, or other reasons that make the patient unsuitable for participation in this clinical trial;

Trial locations and contacts

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

Ming Chen, Doctor. contact

0571-87236557

zychenming@zju.edu.cn

China1 site
  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate in Advanced Pancreatic Cancer:A Multi-center, Single-arm, Phase II Exploratory Trial

This study is a multicenter, single-arm, phase II exploratory study, aims to evaluate the efficacy and safety of metronomic capecitabine with camrelizumab and apatinib mesylate in advanced pancreatic cancer after the failure of first-line treatment.

Read the detailed description

This study used a Simon two-stage design, with at least 43 subjects enrolled, includs the patients with advanced pancreatic cancer whose second-line treatment has failed, or those with poor performance status (PS score >1) who cannot tolerate the second-line regimen with two or more chemotherapeutic drugs. All subjects enrolled receive the treatment of metronomic capecitabine with camrelizumab and apatinib mesylate until disease progression or intolerable toxicity or the ended of study.

Being tested
Metronomic capecitabine, Camrelizumab, Apatinib Mesylate Tablets
Keywords
Metronomic chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Metronomic capecitabineDrug

    Metronomic capecitabine: 650 mg/m2, twice daily, to be swallowed with water within 30 minutes after a meal;

  • CamrelizumabDrug

    Camrelizumab: a PD-1 inhibitor, 200 mg, intravenous injection once every 2 weeks;

  • Apatinib Mesylate TabletsDrug

    Apatinib mesylate: a small molecule of tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2) , 250mg, once daily, to be swallowed with water within 30 minutes after a meal.

Study groups in NCT06759090
Study groupRoleWhat they receive
Arm AExperimentalMetronomic capecitabine: 650 mg/m2, twice daily, to be swallowed with water within 30 minutes after a meal; Camrelizumab: 200 mg, intravenous injection once every 2 weeks; Apatinib mesylate: 250mg, once daily, to be swallowed with water within 30 minutes after a meal;
Receives: Drug: Metronomic capecitabine; Drug: Camrelizumab; Drug: Apatinib Mesylate Tablets

What is being measured

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

  1. Objective Response Rate (ORR)

    The proportion of patients who had tumor evaluated as CR/PR according to irRECIST1.1 criteria during the whole study.

    Measured: Up to 18 months

  2. Disease Control Rate (DCR)

    The proportion of patients who had tumor evaluated as CR/PR/SD according to irRECIST1.1 criteria during the whole study.

    Measured: Up to 18 months

  3. Safety of treatment

    Evaluate the grading of blood test abnormalities and other adverse drug reaction according to CTCAE 5.0.

    Measured: Up to 18 months

Secondary outcomes (4)
  1. The quality of life

    The EORTC QLQ-C30 scoring scale was adopted to evaluate the quality of life of patients with advanced pancreatic cancer.

    Measured: Up to 18 months

  2. Overall Survival (OS)

    The time from enrolled to death due to any cause during the whole study.

    Measured: Up to 18 months

  3. Progression-free Survival (PFS)

    The time from enrolled to disease progression or death due to any cause during the whole study.

    Measured: Up to 18 months

  4. Response Rate of CA199

    At least one serum CA199 value decreased by 50% or more that compared with the baseline level before treatment.

    Measured: Up to 18 months

Timeline

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

  1. First posted6 Jan 2025
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Jun 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759090
Sponsor's protocol ID
mCIV-PC-01
Status last verified
Dec 2024
First submitted
29 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metronomic capecitabine, Camrelizumab and Apatinib Mesylate Tablets in people with Metastatic Pancreatic Carcinoma, run by Zhejiang 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 3 inclusion and 5 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 6 Jan 2025. 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?

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 Ming Chen, Doctor. (0571-87236557, zychenming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Jan 2025.

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