A Trial Of Camrelizumab Combined With Ablation And Chemotherapy In Patients With Pancreatic Cancer Liver Metastasis（SHR-1210-HLJ-009）

Study Overview

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

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.

N/A

Pancreatic Cancer
Liver Metastasis

DRUG: Camrelizumab
DRUG: Chemotherapy
PROCEDURE: Ablation

SHR-1210-HLJ-009

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-06-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-10-01
First Submitted that Met QC Criteria 2020-06-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-10-04
First Posted (ACTUAL) 2020-06-09	Results First Posted N/A	Last Verified 2022-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Camrelizumab combined with ablation and chemotherapy 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 pe	DRUG: Camrelizumab Camrelizumab was administered 200mg iv every 3 weeks DRUG: 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Camrelizumab combined with ablation and chemotherapy

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 pe

DRUG: Camrelizumab

Camrelizumab was administered 200mg iv every 3 weeks

DRUG: 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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
ORR	Overall Response Rate	From the first drug administration up to two years
DCR	Disease Control Rate	From the first drug administration up to two years
PFS	Progression Free Survival	From the first drug administration up to two years
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Yanqiao Zhang, PhD, Harbin Medical University Cancer Hosptital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record