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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Cancer; Liver Metastasis
• Intervention / Treatment: Drug: Camrelizumab; Drug: Chemotherapy; Procedure: Ablation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yanqiao Zhang
• Investigators: Principal Investigator: yanqiao zhang, phD, Harbin Medical University Cancer Hosptital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Liver Diseases; Neoplastic Processes; Pancreatic Diseases; Neoplasm Metastasis; Pancreatic Neoplasms; Liver Neoplasms
• Other Study ID Numbers: SHR-1210-HLJ-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No