A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD

May 6, 2024 updated by: Rui-hua Xu, MD, PhD
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • SunYat-senUniversity Cancer Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have full understanding of this study and voluntarily sign the informed consent form;
  2. Male and Female aged between 18 and 75 years are eligible;
  3. Histologically or cytologically confirmed metastatic pancreatic cancer;
  4. Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy;
  5. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  7. Predicted survival ≥12 weeks;
  8. Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.

Exclusion Criteria:

  1. Participated in other anti-tumor drug clinical trials within 28 days;
  2. Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
  3. Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
  4. Those who are known to be allergic to any of the drugs in the study;
  5. Brain metastasis accompanied by symptoms or symptom control time <2 months;
  6. The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);

  7. Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):

    1. Absolute neutrophil count (ANC) <1.5×109/L;
    2. Platelets <100×109/L;
    3. Hemoglobin <8g/dL.

  8. Liver abnormalities:

    1. When there is no liver metastasis, ALT, AST or ALP>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP>5×ULN;
    2. Serum total bilirubin >1.5×ULN (Gilber syndrome >3×ULN);
    3. Decompensated cirrhosis (Child-Pugh liver function grade B or C);
    4. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU/mL (those who are HBsAg positive and hepatitis B virus DNA copy number <2000IU/mL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;
    5. Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.

  9. Kidney abnormalities:

    1. Serum creatinine>1.5×ULN;
    2. Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be >1.0g;
    3. Renal failure requiring hemodialysis or peritoneal dialysis;
    4. Past history of nephrotic syndrome.；

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Surufatinib in combination with Camrelizumab and mFOLFOX6
Drug: Surufatinib 250mg/d qd once daily
mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles.
Other Names:
  • Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 years

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: Time Frame: up to 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Time Frame: up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
disease control rate (DCR)
Time Frame: Time Frame: up to 24 months
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Time Frame: up to 24 months
Progression-Free Survival (PFS)
Time Frame: Time Frame: up to 24 months
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time Frame: up to 24 months
overall survival (OS)
Time Frame: Time Frame: up to 24 months
OS is the time from enrollment to death due to any cause.
Time Frame: up to 24 months
quality of life (QoL)
Time Frame: Time Frame: up to 24 months
Assessing the quality of life of cancer patients by QLQ-C30
Time Frame: up to 24 months
adverse events (AE)
Time Frame: Time Frame: up to 24 months
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Time Frame: up to 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rui-hua Xu, MD, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rui Hua Xu, MD, Sun Yat-sen University

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMPL-012-SPRING-P106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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