Pancreatic CancerNCT04420130
A Trial of Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis（SHR-1210-HLJ-009）
A study testing Camrelizumab, Chemotherapy and Ablation in people with Pancreatic Cancer and Liver Metastasis, run by Yanqiao Zhang.
Trial summary
This is a a single-arm, prospective study of Camrelizumab combined with ablation and chemotherapy for patients with Pancreatic cancer liver metastasis. The main purpose of this study is to evaluate the safety and tolerability of Camrelizumab combined with ablation and chemotherapy as a treatment of Pancreatic cancer… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer, Liver Metastasis
- What is being tested?
- Camrelizumab, Chemotherapy and Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with liver metastasis of pancreatic cancer diagnosed by histology or cytology;
- Must have CT or MRI examination in the last 3 months;
- With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
- Expected survival time> 3 months;
- The interval between the end of the patient's previous chemotherapy or adjuvant chemotherapy must be more than 6 months;
- No radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area);
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- Must score pain;
- Age: 18 to 70 years old, male or female;
- ECOG PS: 0-1 points;
- The functions of important organs meet the following requirements:
- Absolute neutrophil count ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9g/dL;
- Bilirubin ≤ 1.5 times ULN (patients drained by retrograde technique may be included); ALT and AST ≤ 5 times ULN;
- Creatinine <120 μmol/L, or MDRD creatinine clearance rate> 60 mL/min;
- Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 6 months after the last dose of treatment Contraceptive measures;
- Signature of patient information and informed consent.
Who cannot join
- Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
- During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
- Those who are allergic to test drugs;
- Presence of ≥2 grade neuropathy (CTCAE 5.0);
- Uncontrolled, symptomatic brain metastases or those with a history of difficult-to-control mental illness or severe intellectual or cognitive dysfunction;
- Suffering from active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism and the need for bronchodilators Treatment of asthma, etc.). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be selected;
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- Have been vaccinated or will be vaccinated with live vaccine within 30 days before the administration of Camrelizumab;
- Congestive heart failure, uncontrolled arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery;
- Suffering from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled;
- Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
- The patient has already participated in another clinical trial;
- People deprived of their liberty or guardianship;
- Unable to receive medical supervision during the trial due to geographical, social or psychological reasons;
- Patients who cannot follow the trial protocol or cannot cooperate with follow-up;
- The researchers believe that it is not appropriate to participate in this experiment.
About this study
Official title: Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis: a Single-arm, Prospective Study
This is a a single-arm, prospective study of Camrelizumab combined with ablation and chemotherapy for patients with Pancreatic cancer liver metastasis.
The main purpose of this study is to evaluate the safety and tolerability of Camrelizumab combined with ablation and chemotherapy as a treatment of Pancreatic cancer liver metastasis.
- Conditions
- Pancreatic Cancer, Liver Metastasis
- Being tested
- Camrelizumab, Chemotherapy, Ablation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab was administered 200mg iv every 3 weeks
ChemotherapyDrug
The chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer.
AblationProcedure or surgery
First give pancreatic cancer patients with liver metastases to ablation of liver metastases
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with ablation and chemotherapy | Experimental | First, patients with liver metastases from pancreatic cancer are given ablation of liver metastases, and conventional chemotherapy plus camrelizumab is performed 1 week after surgery. If patients have multiple metastases, ablation treatment needs to be performed in stages, each ablation After 1 week of treatment, sequential chemotherapy + camrelizumab were reinfused, and the efficacy was evaluated every 2 cycles until the disease progressed or the patient could not tolerate it. Receives: Drug: Camrelizumab; Drug: Chemotherapy; Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS rate
6-month progression-free survival rate
Measured: From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Secondary outcomes (4)
ORR
Overall Response Rate
Measured: From the first drug administration up to two years
DCR
Disease Control Rate
Measured: From the first drug administration up to two years
PFS
Progression Free Survival
Measured: From the first drug administration up to two years
Incidence of Treatment-Emergent Adverse Events
adverse events/serious adverse events
Measured: from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Why it stopped: Failed to pass ethics committee review
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanqiao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqiao Zhang, Harbin Medical University
- Investigators
- Yanqiao Zhang, PhD, Principal investigator, Harbin Medical University Cancer Hosptital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420130
- Sponsor's protocol ID
- SHR-1210-HLJ-009
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis: a Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT04420130
- Acronym / sponsor ID
- SHR-1210-HLJ-009
- Conditions
- Pancreatic Cancer, Liver Metastasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failed to pass ethics committee review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yanqiao ZhangUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Jun 2020 (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 a single-arm, prospective study of Camrelizumab combined with ablation and chemotherapy for patients with Pancreatic cancer liver metastasis.
The main purpose of this study is to evaluate the safety and tolerability of Camrelizumab combined with ablation and chemotherapy as a treatment of Pancreatic cancer liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab combined with ablation and chemotherapy | Experimental | Drug: Camrelizumab, Drug: Chemotherapy, Procedure: AblationFirst, patients with liver metastases from pancreatic cancer are given ablation of liver metastases, and conventional chemotherapy plus camrelizumab is performed 1 week after surgery. If patients have multiple metastases, ablation treatment needs to be performed in stages, each ablation After 1 week of treatment, sequential chemotherapy + camrelizumab were reinfused, and the efficacy was evaluated every 2 cycles until the disease progressed or the patient could not tolerate it. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with liver metastasis of pancreatic cancer diagnosed by histology or cytology;
- Must have CT or MRI examination in the last 3 months;
- With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
- Expected survival time> 3 months;
- The interval between the end of the patient's previous chemotherapy or adjuvant chemotherapy must be more than 6 months;
Key exclusion criteria (15 listed)
- Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
- During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
- Those who are allergic to test drugs;
- Presence of ≥2 grade neuropathy (CTCAE 5.0);
- Uncontrolled, symptomatic brain metastases or those with a history of difficult-to-control mental illness or severe intellectual or cognitive dysfunction;
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 |
|---|---|---|
| CamrelizumabCamrelizumab was administered 200mg iv every 3 weeks | Drug | Camrelizumab combined with ablation and chemotherapy |
| ChemotherapyThe chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer. | Drug | Camrelizumab combined with ablation and chemotherapy |
| AblationFirst give pancreatic cancer patients with liver metastases to ablation of liver metastases | Procedure or surgery | Camrelizumab combined with ablation and chemotherapy |
Primary outcome
6-month PFS rate
Time frame: From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
6-month progression-free survival rate
4 secondary outcomes
ORR
Time frame: From the first drug administration up to two years
DCR
Time frame: From the first drug administration up to two years
PFS
Time frame: From the first drug administration up to two years
Incidence of Treatment-Emergent Adverse Events
Time frame: from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Yanqiao Zhang, PhD principal investigator
Harbin Medical University Cancer Hosptital
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab, Chemotherapy and Ablation in people with Pancreatic Cancer and Liver Metastasis, run by Yanqiao Zhang.
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 15 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: withdrawn, as of the sponsor's last update on 4 Oct 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
6-month PFS rate (time frame: From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed 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 4 Oct 2022.