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NCT Number: NCT06166589

Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer

This is a prospective, single arm, phase II clinical study investigating second-line Zimberelimab and SIROX chemotherapy for patient with previously AG chemotherapy treated pancreatic cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location contact

Liang Liu, MD, PhD

PRINCIPAL_INVESTIGATOR

Wei Sun, MD, PhD

CONTACT

[email protected]

+86 21 31587861

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are at least 18 years old when signing the informed consent, both male and female.
  • Patients with pancreatic cancer progressing after first-line AG regimen chemotherapy, including patients with advanced pancreatic cancer progressing after first-line AG regimen chemotherapy and patients with recurrence and metastasis after radical pancreatic cancer surgery assisted by AG regimen chemotherapy.
  • Having not been previously treated with oxaliplatin, S-1, irinotecan and PD-1/L1 antibody.
  • According to the judgment of the attending physician, it is appropriate to receive sepalizumab treatment.
  • According to RECIST1.1, Patients must have measurable target lesions examined by CT or MRI.
  • ECOG PS score: 0-1.
  • Expected survival time ≥3 months.
  • All screening period laboratory tests should be performed as required by the protocol and within 14 days prior to the first dose.
  • Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female Patients of reproductive age and male Patients whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug.
  • Voluntarily participate in clinical research and sign informed consent.

Exclusion criteria

  • Patients have any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Patients with vitiligo or complete remission of asthma in childhood without any intervention after adulthood can be included;Patients with asthma requiring medical intervention with bronchodilators cannot be included);
  • Patients are using immunosuppressants, or systemic, or absorbable topical hormone therapy for immunosuppression purposes (dose > 10mg/day prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment;
  • Severe allergic reactions to all drugs and excipients involved in the study;
  • Clinical cardiac symptoms or diseases that have not been well controlled, such as: (1) NYHA2 or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • Urine routine suggests proteinuria ≥++, or confirmed 24-hour urinary protein ≥1.0g;
  • Patients have active infection or unexplained fever >38.5 degrees during screening and before the first dose; 7. The Patients have congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value);
  • The Patients have used other drugs in clinical trials within 4 weeks before the first dose;
  • The Patients have suffered from other malignant tumors in the past or at the same time;
  • The Patients may receive other systemic anti-tumor treatment during the study period;
  • The patients with bone metastasis have received palliative radiotherapy in the area >5% of the bone marrow area within 4 weeks before participating in the study;
  • The Patients have been vaccinated less than 4 weeks before the study dose or may be vaccinated during the study period;
  • In the judgment of the researchers, the Patients have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors that may affect the safety of the Patients, or the collection of data and samples. In the judgment of the researchers, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, drug abuse, other serious diseases (including mental illness) that need combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of medication.

Treatment and study plan

Zimberelimab

Drug

Zimberelimab, 240mg, day1. Every 3 weeks as a cycle.

Oxaliplatin

Drug

Oxaliplatin 60mg/m2, day1、day8. Every 3 weeks as a cycle.

S-1

Drug

S-1(BSA < 1.2m2, 40 mg/day; BSA = 1.2~1.4 m2, 60 mg/day; BSA = 1.4~1.6 m2, 80 mg/day; BSA > 1.6 m2, 100 mg/day; bid, day1-14). Every 3 weeks as a cycle.

Irinotecan

Drug

Irinotecan, 130 mg/m2, day 1, day 8. Every 3 weeks as a cycle.

Primary outcomes

  1. ORR

    Time frame: one year

    Objective response rate based on RECIST v1.1

Secondary outcomes

  1. adverse events

    Time frame: two years

    adverse events evaluation based on NCI-CTCAE 5.0

  2. DCR

    Time frame: one year

    Disease control rate evaluation based on RECIST v1.1

  3. PFS

    Time frame: two years

    Progression free survival time

  4. OS

    Time frame: three years

    overall survival time

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Liu, MD, PhD

CONTACT

[email protected]

021-31587861

Wen-Quan Wang, MD, PhD

CONTACT

[email protected]

021-31587861

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer: A Prospective, Single Arm, Phase II Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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