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Advanced Pancreatic CancerPhase 2Nim-PC-28NCT06422156

SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer

A Phase 2 study testing Stereotactic body radiation, Nimotuzumab and mono-chemotherapy in people with Advanced Pancreatic Cancer, run by Peking University Third Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Stereotactic body radiation, Nimotuzumab and mono-chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Jun 2026
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

  • 1. Age 18-75 years old, gender unlimited;
  • 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
  • 3. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined;
  • 4. The maximum diameter of the primary tumor was < 5.0cm;
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • 6. No prior radiotherapy (upper abdomen) or tumor systemic therapy;
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  • 7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN;
  • 8. Left ventricular ejection fraction ≥50%;
  • 9. Fertile subjects are willing to take contraceptive measures during the study period;
  • 10. Woman who are breastfeeding during the study period or within 150 days after the last treatment;
  • 11. Survival was expected to be ≥3 months;
  • 12.Good compliance and signed informed consent voluntarily.

Who cannot join

  • 1. Tumor invasion of gastrointestinal tract;
  • 2. Woman who are pregnant or breastfeeding;
  • 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years;
  • 4. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence;
  • 5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months;
  • 6. Patients requiring immunosuppressive;
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  • 7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease;
  • 8. Known allergy to prescription or any component of the prescription used in this study;
  • 9. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention;
  • 10. Patients with acute and chronic tuberculosis infection;
  • 11. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration;
  • 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
  • 13. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration;
  • 14. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration;
  • 15.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Trial locations and contacts

No sites are listed yet.

Bin Qiu, MD contact

+86 010-82265968

qiubin@pku.edu.cn

About this study

Official title: A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer

This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC).

Read the detailed description

This clinical study is designed as a prospective, multicenter, single arm study to evaluate the clinical efficacy and safety of SBRT combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). All eligible patients will receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression, death, unacceptable toxicity, or consent withdrawal. The main endpoint is progression-free survival (PFS).

Being tested
Stereotactic body radiation, Nimotuzumab, mono-chemotherapy
Keywords
advanced pancreatic cancer, stereotactic body radiation therapy (SBRT), Nimotuzumab

What participants receive

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

  • Stereotactic body radiationRadiation

    Also called SBRT

    Patients will receive SBRT with doses ranging from 35-40 Gy in five fractions.

  • NimotuzumabDrug

    Also called h-R3

    Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg on day 1 and 8 of a 21-day cycle until disease progression.

  • mono-chemotherapyDrug

    Also called chemotherapy

    Patients will receive mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression.

Study groups in NCT06422156
Study groupRoleWhat they receive
SBRT+Nimotuzumab+ mono-chemotherapyExperimentalAll eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
Receives: Radiation: Stereotactic body radiation; Drug: Nimotuzumab; Drug: mono-chemotherapy

What is being measured

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

  1. progression-free survival (PFS)

    PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Up to 12 months

Secondary outcomes (5)

  1. overall survival (OS)

    The time from the beginning of treatment to death due to any cause.

    Measured: Up to 12 months

  2. Objective response rate (ORR)

    Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.

    Measured: Up to 12 months

  3. Disease control rate (DCR)

    Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).

    Measured: Up to 12 months

  4. Pain relief rate

    The proportion of patients with pain relief after treatment to the total number enrolled.

    Measured: Up to 12 months

  5. adverse events

    Frequency and severity of adverse events.

    Measured: Up to 30 days after last administration

Timeline

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

  1. First posted20 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (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
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422156
Sponsor's protocol ID
M2023639
Acronym
Nim-PC-28
Status last verified
Nov 2023
First submitted
17 Mar 2024
Last updated
20 May 2024
Results posted
No
Data monitoring committee
Yes
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 Stereotactic body radiation, Nimotuzumab and mono-chemotherapy in people with Advanced Pancreatic Cancer, run by Peking University Third Hospital.

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 12 inclusion and 15 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 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Bin Qiu, MD (+86 010-82265968, qiubin@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) (time frame: Up to 12 months). 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 NCT06422156.

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 20 May 2024.

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