Pancreatic CancerPhase 2NCT06404840
Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study
A Phase 2 study testing nimotuzumab and AG chemotherapy in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). 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 chemotherapy
- 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
- 6 May 2022to 31 May 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; 2) Physical strength KPS ≥ 60 points; 3) Pancreatic ductal epithelial adenocarcinoma with liver metastasis that has been diagnosed by pathological histology or cytology and is not suitable for radical radiotherapy or surgical treatment (should be at least 6 months away from the last adjuvant chemotherapy); 4) According to the RECIST 1.1 evaluation criteria, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion on spiral CT examination should be ≥ 10mm; if there is only lymph node metastasis, the shortest diameter should be ≥ 15mm); 5) Expected survival time ≥ 3 months; 6) Serum AST/ALT ≤ 5 times ULN; Total bilirubin ≤ 3 times ULN; Absolute count of granulocytes ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Creatinine clearance rate ≥ 60ml/min; 7) Voluntarily participate in this study, sign an informed consent form, and have good compliance; 8) Patients of childbearing age and their spouses are willing to take contraceptive measures.
Who cannot join
- 1) Prior to this study, the following treatments were received:
- Antitumor chemotherapy and molecular targeted therapy as a palliative measure
- The target lesion has undergone radiotherapy without any progression
- Within 4 weeks or currently participating in other therapeutic/intervention clinical trials 2) Received major surgery within 4 weeks; 3) Existing brain metastasis or leptomeningeal metastasis; 4) Have a history of other malignancies other than pancreatic cancer (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for 5 years); 5) Merge symptomatic abdominal fluid that requires clinical treatment; 6) Accompanied by other serious illnesses, including but not limited to:
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- Uncontrollable congestive heart failure (NYHA grade III or IV, see Appendix III), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to high blood pressure (SBP>160mmHg or DBP>100mmHg)
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- Active infection
- Difficult to control diabetes
- Mental illnesses that affect informed consent and/or adherence to protocols
- HIV infection
- There are serious illnesses that other researchers believe are not suitable for participating in this study 7) Known to be allergic to anti EGFR antibody preparations. 1.3 Exclusion criteria
- Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Huikai Li, Doctor, 18622228639, tjchlhk@126.com
Yang Liu, MD, 17694950696, tjchlhk@126.com
About this study
Official title: Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases (PCLM): A Prospective, Single-Arm, Phase II Study
Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.
- Conditions
- Pancreatic Cancer
- Being tested
- nimotuzumab, AG 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.
nimotuzumabDrug
nimotuzumab (400 mg, iv, d1, qw)
AG chemotherapyDrug
(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)
| Study group | Role | What they receive |
|---|---|---|
| AG+nimotuzumab | Experimental | Pts with potentially resectable, treatment-naïve PCLM received nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle). Receives: Drug: nimotuzumab; Drug: AG chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Primary endpoints were adverse events (AEs),
Measured: 3month
Secondary outcomes (3)
surgical conversion rates
surgical conversion rates
Measured: 3month
R0 resection rates
R0 resection rates
Measured: 3month
pathological complete response (pCR) rate
pathological complete response (pCR) rate
Measured: 3month
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 start6 May 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2026 (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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404840
- Sponsor's protocol ID
- AG plus Nimotuzumab
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- 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
- Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases (PCLM): A Prospective, Single-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06404840
- Acronym / sponsor ID
- AG plus Nimotuzumab
- 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
- 6 May 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2026 (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.
Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG+nimotuzumab | Experimental | Drug: nimotuzumab, Drug: AG chemotherapyPts with potentially resectable, treatment-naïve PCLM received nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age: 18-75 years old; 2) Physical strength KPS ≥ 60 points; 3) Pancreatic ductal epithelial adenocarcinoma with liver metastasis that has been diagnosed by pathological histology or cytology and is not suitable for radical radiotherapy or surgical treatment (should be at least 6 months away from the last adjuvant chemotherapy); 4) According to the RECIST 1.1 evaluation criteria, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion on spiral CT examination should be ≥ 10mm; if there is only lymph node metastasis, the shortest diameter should be ≥ 15mm); 5) Expected survival time ≥ 3 months; 6) Serum AST/ALT ≤ 5 times ULN; Total bilirubin ≤ 3 times ULN; Absolute count of granulocytes ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Creatinine clearance rate ≥ 60ml/min; 7) Voluntarily participate in this study, sign an informed consent form, and have good compliance; 8) Patients of childbearing age and their spouses are willing to take contraceptive measures.
Key exclusion criteria (12 listed)
- 1) Prior to this study, the following treatments were received:
- <!-- -->
- Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.
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 |
|---|---|---|
| nimotuzumabnimotuzumab (400 mg, iv, d1, qw) | Drug | AG+nimotuzumab |
| AG chemotherapy(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle) | Drug | AG+nimotuzumab |
Primary outcome
AEs
Time frame: 3month
Primary endpoints were adverse events (AEs),
3 secondary outcomes
surgical conversion rates
Time frame: 3month
R0 resection rates
Time frame: 3month
pathological complete response (pCR) rate
Time frame: 3month
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.
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 chemotherapy 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 1 inclusion and 12 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: 3month). 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.