Pancreatic CancerPhase 2NCT06405685
Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis
A Phase 2 study testing Nimotuzumab and AG in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Nimotuzumab and AG
- 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
- 27 Apr 2023to 30 Oct 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
- 1. Age 18-75 years old, gender unlimited;
- 2. Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
- 3. Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
- 4. Receive nimotuzumab-based conversion therapy for voluntary;
- 5. No prior tumor systemic therapy;
- 6. Measurable disease according to RECIST criteria v1.1;
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- 7. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/L; serum total bilirubin (TBIL)≤3×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
- 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 9. Life expectancy is expected to be ≥3 months;
- 10. Fertile subjects are willing to take contraceptive measures during the study period.
- 11. Good compliance and signed informed consent voluntarily.
Who cannot join
- 1. Refuse chemotherapy or surgery;
- 2. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
- 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 4. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 5. Undergone major surgery within 30 days;
- 6. Use of EGFR-mab or EGFR-TKI within 30 days;
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- 7. Known allergy to prescription or any component of the prescription used in this study;
- 8. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
- 9. Grade 2 or above toxicity from prior treatment that has not resolved (excluding anemia, alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity)
- 10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Huikai Li, Dr
About this study
Official title: A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
Read the detailed description
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
- Conditions
- Pancreatic Cancer
- Being tested
- Nimotuzumab, AG
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called h-R3
Nimotuzumab 400 mg will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.
AGDrug
Patients will receive AG as conversion therapy up to 6 months. Gemcitabine 1000 mg/m^2 will be administered on Day 1, 8, 15 of a 28-day cycle. nab-Paclitaxel 125 mg/m^2 will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab+AG | Experimental | Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. Receives: Drug: Nimotuzumab; Drug: AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The Proportion of patients who achieved R0 resection (incisal edge>1cm)
Measured: Up to 6 months
Secondary outcomes (5)
resection rate
The proportion of patients who underwent surgery.
Measured: Up to 18 months
overall survival (OS)
The time from the beginning of treatment to death due to any cause.
Measured: Up to 18 months
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 18 months
tumor-related markers
To explore the influence of tumor-related markers (such as CA199,EGFR) on prognosis.
Measured: Up to 18 months
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.
- First posted8 May 2024
- Study start27 Apr 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, Dr, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405685
- Sponsor's protocol ID
- IST-Nim-PC-5
- Status last verified
- May 2023
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT06405685
- Acronym / sponsor ID
- IST-Nim-PC-5
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
Detailed description
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab+AG | Experimental | Drug: Nimotuzumab, Drug: AGPatients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age 18-75 years old, gender unlimited;
- 2. Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
- 3. Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
- 4. Receive nimotuzumab-based conversion therapy for voluntary;
- 5. No prior tumor systemic therapy;
Key exclusion criteria (10 listed)
- 1. Refuse chemotherapy or surgery;
- 2. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
- 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 4. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 5. Undergone major surgery within 30 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimotuzumabAlso: h-R3Nimotuzumab 400 mg will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery. | Drug | Nimotuzumab+AG |
| AGPatients will receive AG as conversion therapy up to 6 months. Gemcitabine 1000 mg/m^2 will be administered on Day 1, 8, 15 of a 28-day cycle. nab-Paclitaxel 125 mg/m^2 will be administered on Day 1, 8, 15 of a 28-day cycle by intravenous (IV) administration up to 6 cycles. Imaging (CT or MRI) and tumor markers (such as CA19-9) will be assessed every two cycles of the conversion therapy, until met the criteria of resection and underwent surgery. | Drug | Nimotuzumab+AG |
Primary outcome
R0 resection rate
Time frame: Up to 6 months
The Proportion of patients who achieved R0 resection (incisal edge>1cm)
5 secondary outcomes
resection rate
Time frame: Up to 18 months
overall survival (OS)
Time frame: Up to 18 months
Objective response rate (ORR)
Time frame: Up to 18 months
tumor-related markers
Time frame: Up to 18 months
adverse events
Time frame: Up to 30 days after last administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihui Hao, Dr study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab and AG in people with Pancreatic Cancer, 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 11 inclusion and 10 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 8 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 Huikai Li, Dr (186 2222 8639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: Up to 6 months). 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 8 May 2024.