A Trial of Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis（SHR-1210-HLJ-009）

Pancreatic Cancer Clinical Trial

Official title:

Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis: a Single-arm, Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04420130
• Other study ID #: SHR-1210-HLJ-009
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2022
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 liver metastasis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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);
• 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:

1. Absolute neutrophil count =1.5×109/L, platelet =100×109/L, hemoglobin =9g/dL;

2. Bilirubin = 1.5 times ULN (patients drained by retrograde technique may be included); ALT and AST = 5 times ULN;

3. Creatinine <120 µmol/L, or MDRD creatinine clearance rate> 60 mL/min;

• Women of childbearing age must undergo a negative pregnancy test (ßHCG) 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.

Exclusion Criteria:

• 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;
• 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.

Related Conditions & MeSH terms

• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Camrelizumab
Camrelizumab was administered 200mg iv every 3 weeks
• Chemotherapy
The chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer.

Procedure:
• Ablation
First give pancreatic cancer patients with liver metastases to ablation of liver metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yanqiao Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month PFS rate	6-month progression-free survival rate	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	ORR	Overall Response Rate	From the first drug administration up to two years
Secondary	DCR	Disease Control Rate	From the first drug administration up to two years
Secondary	PFS	Progression Free Survival	From the first drug administration up to two years
Secondary	Incidence of Treatment-Emergent Adverse Events	adverse events/serious adverse events	from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy