Stage IV Pancreatic CancerPhase 1NCT05240690
Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies
A Phase 1 study testing Umbilical Cord Blood Derived MAK Immune Cells in people with Stage IV Pancreatic Cancer and Hepatocellular Carcinoma , Cholangiocarcinoma, run by Zhou Fuxiang at 1 site in China.
Trial summary
To evaluate the safety of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.And to investigate the initial efficacy of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Pancreatic Cancer, Hepatocellular Carcinoma , Cholangiocarcinoma
- What is being tested?
- Umbilical Cord Blood Derived MAK Immune Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2022to 31 Dec 2024
- Phase
- Phase 1
- 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
- Age over 18 years old, under 75 years old, men and women;
- Subjects participated voluntarily, gave full informed consent, signed a written informed consent, with good compliance;
- Hepatocytic carcinoma or biliary or pancreatic-derived adenocarcinoma was clearly diagnosed by histological or cytology pathology;
- Recurrent hepatobiliary or pancreatic malignancies with unresectable advanced or metastatic, or postoperative adjuvant therapy (chemotherapy and / or radiation therapy) for 12 months, with a Child-Pugh score of 7;
- With 1 measurable lesion, according to the RECIST v 1.1 criteria.Requirements: The selected target lesion has not previously received local treatment, or the selected target lesion was located in the previous local treatment area after passing the imaging examination and was determined as PD according to the RECIST v 1.1 criteria;
- ECOG score of 0-1;
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- Expected survival is greater than 3 months;
- Main organ function composite with the following requirements:
- Absolute neutrophil count was 1.5*10^9 / L;
- Platelet count was 75*10^9 / L;
- Hemoglobin was at 90g / L;
- Serum albumin at 30g / L;
- Serum bilirubin 1.5 upper Range normal limit (ULN);
- Altraverine aminotransferase (ALT), aspartate aminotransferase (AST) 2.5 upper normal range limit (ULN);
- Serum creatinine (Cr) 1.5 Upper Limit of normal range (ULN) or Cr clearance of 40 mL/min;
- The International standardized ratio (INR) 2 or Prothrombin Time (PT) exceeds the upper limit of the normal range for 6 seconds;
- Urinary protein <2 + (if urine protein 2 +, 24 h (h), and 24h <1.0g can be enrolled).
- 9.If HBsAg (+) and / or HBcAb (+), HBV DNA must be <500IU / mL and during the study period, the original anti-HBV treatment continues throughout the study, or start entecavir or teenofavir.
- 10.There is no previous history of abdominal radiotherapy. If radiation has been performed, the complete target area scope and treatment plan are more than 2 weeks apart from the study immune cell transfusion of this project; 11.No history of organ transplantation; 12.Women of childbearing age performed a serum pregnancy test within 7 days before the initiation of treatment, and agreed to adopt a reliable and effective contraceptive method during the trial and within 60 days after the final administration of the test drug.For male subjects with a partner of women of childbearing age, consent was given to a reliable and effective approach to contraception during the trial and within 60 days after the final administration of the test medication.
Who cannot join
- At the same time, there are serious medical diseases, including serious heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active digestive tract ulcer;
- Patients with brain metastasis with clinical symptoms;
- Suffering from other primary malignancies in the past 5 years (except skin BCC or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- Patients with immunodeficiency or autoimmune diseases (e. g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, insulin-dependent diabetes, etc.).
- Patients who participated in other clinical trials or clinical study treatment within the 3 months prior to this clinical study.
- Patients treated with other cells within the last 6 months.
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- Patients with infection and fever who were not effectively controlled.
- Patients with high allergies or a history of severe allergies.
- Patients with an albumin allergy.
- Patients after organ transplantation; patients with long-term use or who are using immunosuppressants.
- Patients with severe other organ dysfunction.
- Patients with organ bleeding, severe hypertension, and patients with a cardiac pacemaker.
- Women during pregnancy or lactation; or women of childbearing age have positive blood pregnancy, women of childbearing age and their spouses are unwilling to take effective contraception during the clinical study and within 6 months of the end.
- Patients who are not considered appropriate to participate in this clinical study (e. g., poor compliance, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies：HCCSC AB04 Trial
To evaluate the safety of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.And to investigate the initial efficacy of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.
- Being tested
- Umbilical Cord Blood Derived MAK Immune Cells
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood Derived MAK Immune CellsBiological
Also called Second-line standard treatment
Intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood Derived MAK Immune Cells | Experimental | Not described Receives: Biological: Umbilical Cord Blood Derived MAK Immune Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival(PFS)
PFS is defined as the time from enrollment to the first documented disea
Measured: 24 months
Secondary outcomes (3)
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: 24 months
objective response rate (ORR)
and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 24 months
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start7 Feb 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Pancreatic CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Fuxiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Fuxiang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240690
- Sponsor's protocol ID
- HCCSC AB04
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies：HCCSC AB04 Trial
- ClinicalTrials.gov ID
- NCT05240690
- Acronym / sponsor ID
- HCCSC AB04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Zhou FuxiangUniversity, hospital or other
- Study start
- 7 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2022 (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.
To evaluate the safety of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.And to investigate the initial efficacy of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood Derived MAK Immune Cells | Experimental | Biological: Umbilical Cord Blood Derived MAK Immune Cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age over 18 years old, under 75 years old, men and women;
- Subjects participated voluntarily, gave full informed consent, signed a written informed consent, with good compliance;
- Hepatocytic carcinoma or biliary or pancreatic-derived adenocarcinoma was clearly diagnosed by histological or cytology pathology;
- Recurrent hepatobiliary or pancreatic malignancies with unresectable advanced or metastatic, or postoperative adjuvant therapy (chemotherapy and / or radiation therapy) for 12 months, with a Child-Pugh score of 7;
- With 1 measurable lesion, according to the RECIST v 1.1 criteria.Requirements: The selected target lesion has not previously received local treatment, or the selected target lesion was located in the previous local treatment area after passing the imaging examination and was determined as PD according to the RECIST v 1.1 criteria;
Key exclusion criteria (14 listed)
- At the same time, there are serious medical diseases, including serious heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active digestive tract ulcer;
- Patients with brain metastasis with clinical symptoms;
- Suffering from other primary malignancies in the past 5 years (except skin BCC or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- Patients with immunodeficiency or autoimmune diseases (e. g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, insulin-dependent diabetes, etc.).
- Patients who participated in other clinical trials or clinical study treatment within the 3 months prior to this clinical study.
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 |
|---|---|---|
| Umbilical Cord Blood Derived MAK Immune CellsAlso: Second-line standard treatmentIntravenous drip | Biological | Umbilical Cord Blood Derived MAK Immune Cells |
Primary outcome
Progression-free Survival(PFS)
Time frame: 24 months
PFS is defined as the time from enrollment to the first documented disea
3 secondary outcomes
overall survival (OS)
Time frame: 24 months
objective response rate (ORR)
Time frame: 24 months
disease control rate (DCR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- 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 1 study testing Umbilical Cord Blood Derived MAK Immune Cells in people with Stage IV Pancreatic Cancer and Hepatocellular Carcinoma , Cholangiocarcinoma, run by Zhou Fuxiang 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 19 inclusion and 14 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 15 Feb 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Fuxiang Zhou (+86-027-67813155, happyzhoufx@sina.com), 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: 24 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 15 Feb 2022.