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NCT Number: NCT06532617

Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer

This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Jiang Long, MD

CONTACT

[email protected]

+86 18017317460

Jiang Long, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Signed written informed consent
  • Age 18-80, female or male
  • Histopathologically confirmed pancreatic ductal adenocarcinoma
  • Patients with locally advanced pancreatic cancer who have previously received standard first-line anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
  • Locally advanced pancreatic cancer is defined as follows: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: The tumor contacts the superior mesenteric artery >180˚; c. Pancreatic body and tail: The tumor contacts the superior mesenteric artery or celiac artery >180˚; The tumor contacts the celiac artery and infiltrates the abdominal aorta; d. The tumor invades the jejunal branch of the superior mesenteric artery. Portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, vein occlusion, or involvement of a large range of jejunal branches of the superior mesenteric vein.
  • At least one measurable lesion (RECIST1.1)
  • ECOG PS 0-1
  • Expected survival time>3 months
  • Adequate organ function

Main Exclusion Criteria:

  • Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ)
  • Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices within 4 weeks before the first dose
  • Active autoimmune disease
  • Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Allergic to the active ingredients or excipients of this study drug, cadonilimab, S-1 or capecitabine
  • Have not fully recovered from any toxicity and/or complications caused by the intervention before starting treatment
  • History of HIV
  • Active HBV or HCV
  • Pregnant or breastfeeding women
  • Any severe or uncontrolled systemic disease
  • Active pulmonary tuberculosis
  • People with mental disorders who are unable to cooperate with treatment
  • Uncontrolled infection
  • The investigators assess that the subjects are unable to complete the entire trial process or are otherwise unsuitable for participating in this trial

Treatment and study plan

Cadonilimab+S-1or Capecitabine

Drug

Eligible patients will receive Cadonilimab (6mg/k, iv, D1,Q3W)combined with S-1 (40-60mg po BID Q3W D1-14)or Capecitabine (1250mg/m2, po BID Q3W D1-14)until disease progression or unacceptable toxicity. Patients who had used S-1 in the first line should choose capecitabine; patients who had used capecitabine in the first line should choose S-1; otherwise decided by investigator's choice.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

    Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 2 years

    Defined as the length of time from the first dose to death from any cause.

  2. Progression-free survival (PFS)

    Time frame: Up to 2 years

    Defined as the length of time from the first dose to progression disease or death from any cause.

  3. Disease control rate (DCR)

    Time frame: Up to 2 years

    Defined as the proportion of patients with a complete response, partial response or stable disease to treatment according to RECIST1.1

  4. Duration of response (DoR)

    Time frame: Up to 2 years

    Defined as the length of time from first tumor response (CR or PR) to disease progression (PD) or death.

Other outcomes

  1. Biomarker analysis

    Time frame: Up to 2 years

    Biomarkers that potentially predict efficacy include, but are not limited to, PD-L1 expression and T cell subpopulations in tumor tissue specimens or blood samples and so on.

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A Single-arm Phase II Clinical Study of Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Patients With Advanced Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
May 14, 2025

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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