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

Not Applicable

Withdrawn

• Conditions: Pancreatic Cancer; Liver Metastasis
• Interventions: Drug: Camrelizumab; Drug: Chemotherapy; Procedure: Ablation

• Registration Number: NCT04420130
• Lead Sponsor: Yanqiao Zhang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-08-01
• Primary Completion: 2022-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-01
• Last Update Posted: 2022-10-04
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab combined with ablation and chemotherapy	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.
Camrelizumab combined with ablation and chemotherapy	Ablation	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.
Camrelizumab combined with ablation and chemotherapy	Camrelizumab	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.

Primary Outcome Measures

Name	Time	Method
6-month PFS 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.	6-month progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
ORR	From the first drug administration up to two years	Overall Response Rate
DCR	From the first drug administration up to two years	Disease Control Rate
PFS	From the first drug administration up to two years	Progression Free Survival
Incidence of Treatment-Emergent Adverse Events	from the first drug administration to within 90 days for the last Camrelizumab combined with ablation and chemotherapy	adverse events/serious adverse events