Unresectable Pancreatic CarcinomaPhase 2PACTONCT02767557
Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients
A Phase 2 study testing Tocilizumab, Gemcitabine and nab-Paclitaxel in people with Unresectable Pancreatic Carcinoma, run by Herlev Hospital at 2 sites in 2 countries.
Trial summary
This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Pancreatic Carcinoma
- What is being tested?
- Tocilizumab, Gemcitabine and nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Jan 2017to 1 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Histological or cytological pancreatic adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed
- Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
- Non-curable unresectable locally advanced or metastatic pancreatic carcinoma.
- A modified Glasgow Prognostic Score (mGPS) criteria of 1 or 2 assessed within 14 days of randomization as defined below:
- mGPS of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
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- mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L
- No prior antineoplastic chemotherapy or anti-cancer drugs. Patients who have received neoadjuvant or adjuvant chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease are not eligible
- ECOG/WHO Performance Status (PS) 0-1
- ≥ 4 weeks since prior major surgery, ≥ 2 weeks since prior minor surgery and ≥ 1 week since prior radiation therapy
- Measurable disease using the RECIST1.1 criteria, defined as lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan or MRI
- Fertile men and women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must use secure contraception methods as follows: intrauterine device, double-barrier contraception, as a condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository), vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female, or complete abstinence from sexual intercourse from before 2 months entering the study until 6 months after end of chemotherapy
- Acceptable hematology parameters defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- Platelet count ≥ 100 x 10⁹/L
- Haemoglobin ≥ 5.6 mmol/L
- Acceptable liver function defined as:
- Serum bilirubin < 1.5 x upper limit of normal (ULN)
- ASAT/ALAT < 2.5 x ULN ( < 5 x ULN with known liver metastasis)
- Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (eg, using the Cockroft-Gault formula)
- Subjects must have signed and dated a BIOPAC IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
Who cannot join
- Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia.
- Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a disease free survival of ≥ 5 years.
- History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- Active infection requiring antibiotics within 2 weeks before the study inclusion
- Concurrent congestive heart failure NYHA ( class III - IV )
- Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
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- Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal conditions associated with risk of perforation
- Peripheral neuropathy grade ≥ 2 according to CTCAE v 4.0
- Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
- No known or suspected allergy to the investigational agents or any agents given in association with this trial.
- Pregnant or lactating women.
- Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up.
- Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multinational, Randomized, Phase II Study of the Combination of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab, an IL-6R Inhibitor, as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer.
This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel.
Read the detailed description
The development of new effective treatment strategies remains a major challenge in patients with PC. High levels of IL-6 and presence of a systemic inflammatory response in PC patients have been reported to correlate with worse survival. Preclinical PC models have clearly shown that anti-IL-6-receptor antibody tocilizumab in combination with chemotherapy reduced tumor growth, number of distant metastases and the local recurrence rate. Thus, blockade of IL-6-regulated signaling pathways represents a promising approach in combination with chemotherapy. Elevated C-reactive protein (CRP) alone or in combination with hypoalbuminaemia (Modified Glasgow Prognostic Score - mGPS) are induced by IL-6 and could feasibly represent surrogate markers for IL-6 bioactivity to stratify patients likely to gain benefit through targeting IL-6.
- Conditions
- Unresectable Pancreatic Carcinoma
- Being tested
- Tocilizumab, Gemcitabine, nab-Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called (ACTEMRA®)
Intravenous infusion
GemcitabineDrug
Intravenous infusion
nab-PaclitaxelDrug
Also called ABRAXANE®
Intravenous infusion,
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab & Gemcitabine and nab-Paclitaxel | Experimental | Tocilizumab:
8 mg/kg given I. V. on day 1 over 60 minutes every 28 day cycle.
Gemcitabine:
1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.
Nab-Paclitaxel:
125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Receives: Drug: Tocilizumab; Drug: Gemcitabine; Drug: nab-Paclitaxel |
| Gemcitabine and nab-Paclitaxel | Active comparator | Gemcitabine:
1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.
Nab-Paclitaxel:
125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Receives: Drug: Gemcitabine; Drug: nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 6 months
Measured: Approximately up to 6 months.
Secondary outcomes (8)
Performance status at 3 and 6 months assessed by investigator
Measured: Approximately up to 6 months.
Performance status at 3 and 6 months, assessed by patient
Measured: Approximately up to 6 months.
Progression free survival (PFS), defined as the time from the date of randomization until the earliest date of disease progression
Measured: Randomization to disease progression, or death due to any cause if sooner. Approximately up to 6 months.
Overall survival (OS), defined as the time from the date of randomization until death due to any cause.
Measured: Randomization until death due to any cause. Approximately up to 12 months.
Overall response rate (ORR) (ORR = CR + PR), according to RECIST 1.1.RECIST 1.1
Measured: Approximately up to 6 months.
Disease control rate (DCR), (DCR = CR + PR + SD), according to RECIST 1.1.
Measured: Approximately up to 6 months.
Safety (Data on safety parameters) Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
Measured: Approximately up to 6 months.
Quality of Life (Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0).
Measured: Approximately up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start26 Jan 2017
- Primary completion12 Aug 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Pancreatic CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Principal investigator, Inna Chen, MD, Herlev Hospital
- Investigators
- Inna Chen, MD, Principal investigator, Herlev & Gentofte HospitalOlav Dajani, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767557
- Sponsor's protocol ID
- GI1612
- Acronym
- PACTO
- Status last verified
- Sep 2023
- First submitted
- 6 May 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kjaer LK, Theile S, Madsen K, Johansen JS, Holmstrom MO, Andersen MH, Chen IM. Impact of Liver Metastases on Outcomes With Chemotherapy or Immune Checkpoint Inhibitors in Pancreatic Cancer. Immun Inflamm Dis. 2026 Oct;14(10):e70545. doi: 10.1002/iid3.70545.
PubMed 42836590Chen IM, Johansen JS, Theile S, Silverman LM, Pelz KR, Madsen K, Dajani O, Lim KZM, Lorentzen T, Gaafer O, Koniaris LG, Ferreira AC, Neelon B, Guttridge DC, Ostrowski MC, Zimmers TA, Nielsen D. Randomized Phase II Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab as First-Line Treatment in Advanced Pancreatic Cancer: Survival and Cachexia. J Clin Oncol. 2025 Jun 20;43(18):2107-2118. doi: 10.1200/JCO.23.01965. Epub 2025 May 12.
PubMed 40354592
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Phase II Study of the Combination of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab, an IL-6R Inhibitor, as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT02767557
- Acronym / sponsor ID
- PACTO / GI1612
- Conditions
- Unresectable Pancreatic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel.
Detailed description
The development of new effective treatment strategies remains a major challenge in patients with PC. High levels of IL-6 and presence of a systemic inflammatory response in PC patients have been reported to correlate with worse survival. Preclinical PC models have clearly shown that anti-IL-6-receptor antibody tocilizumab in combination with chemotherapy reduced tumor growth, number of distant metastases and the local recurrence rate. Thus, blockade of IL-6-regulated signaling pathways represents a promising approach in combination with chemotherapy. Elevated C-reactive protein (CRP) alone or in combination with hypoalbuminaemia (Modified Glasgow Prognostic Score - mGPS) are induced by IL-6 and could feasibly represent surrogate markers for IL-6 bioactivity to stratify patients likely to gain benefit through targeting IL-6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab & Gemcitabine and nab-Paclitaxel | Experimental | Drug: Tocilizumab, Drug: Gemcitabine, Drug: nab-PaclitaxelTocilizumab: 8 mg/kg given I. V. on day 1 over 60 minutes every 28 day cycle. Gemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. |
| Gemcitabine and nab-Paclitaxel | Active comparator | Drug: Gemcitabine, Drug: nab-PaclitaxelGemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed informed consent
- Histological or cytological pancreatic adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed
- Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
- Non-curable unresectable locally advanced or metastatic pancreatic carcinoma.
- A modified Glasgow Prognostic Score (mGPS) criteria of 1 or 2 assessed within 14 days of randomization as defined below:
Key exclusion criteria (13 listed)
- Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia.
- Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a disease free survival of ≥ 5 years.
- History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- Active infection requiring antibiotics within 2 weeks before the study inclusion
- Concurrent congestive heart failure NYHA ( class III - IV )
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 |
|---|---|---|
| TocilizumabAlso: (ACTEMRA®)Intravenous infusion | Drug | Tocilizumab & Gemcitabine and nab-Paclitaxel |
| GemcitabineIntravenous infusion | Drug | Gemcitabine and nab-Paclitaxel, Tocilizumab & Gemcitabine and nab-Paclitaxel |
| nab-PaclitaxelAlso: ABRAXANE®Intravenous infusion, | Drug | Gemcitabine and nab-Paclitaxel, Tocilizumab & Gemcitabine and nab-Paclitaxel |
Primary outcome
Overall survival at 6 months
Time frame: Approximately up to 6 months.
8 secondary outcomes
Performance status at 3 and 6 months assessed by investigator
Time frame: Approximately up to 6 months.
Performance status at 3 and 6 months, assessed by patient
Time frame: Approximately up to 6 months.
Progression free survival (PFS), defined as the time from the date of randomization until the earliest date of disease progression
Time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately up to 6 months.
Overall survival (OS), defined as the time from the date of randomization until death due to any cause.
Time frame: Randomization until death due to any cause. Approximately up to 12 months.
Overall response rate (ORR) (ORR = CR + PR), according to RECIST 1.1.RECIST 1.1
Time frame: Approximately up to 6 months.
Disease control rate (DCR), (DCR = CR + PR + SD), according to RECIST 1.1.
Time frame: Approximately up to 6 months.
Safety (Data on safety parameters) Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
Time frame: Approximately up to 6 months.
Quality of Life (Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0).
Time frame: Approximately up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 42836590Kjaer LK, Theile S, Madsen K, Johansen JS, Holmstrom MO, Andersen MH, Chen IM. Impact of Liver Metastases on Outcomes With Chemotherapy or Immune Checkpoint Inhibitors in Pancreatic Cancer. Immun Inflamm Dis. 2026 Oct;14(10):e70545. doi: 10.1002/iid3.70545.
- Derived from this study: PubMed 40354592Chen IM, Johansen JS, Theile S, Silverman LM, Pelz KR, Madsen K, Dajani O, Lim KZM, Lorentzen T, Gaafer O, Koniaris LG, Ferreira AC, Neelon B, Guttridge DC, Ostrowski MC, Zimmers TA, Nielsen D. Randomized Phase II Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab as First-Line Treatment in Advanced Pancreatic Cancer: Survival and Cachexia. J Clin Oncol. 2025 Jun 20;43(18):2107-2118. doi: 10.1200/JCO.23.01965. Epub 2025 May 12.
- Individual participant dataSharing planned: Yes
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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.
Inna Chen, MD principal investigator
Herlev & Gentofte Hospital
Olav Dajani, MD PhD principal investigator
Oslo University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab, Gemcitabine and nab-Paclitaxel in people with Unresectable Pancreatic Carcinoma, run by Herlev Hospital at 2 sites in 2 countries.
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 21 inclusion and 13 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: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 6 months (time frame: Approximately up to 6 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 NCT02767557, which also lists 2 linked publications.
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 22 Sep 2023.