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

NCT06532617 | Recruiting Phase 2

• 1 other identifier: 20240515024702669
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Neoplasms

Keywords

PD-1/CTLA-4 Bispecific Antibody

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

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

  Up to 2 years

Secondary Outcomes (4)

• Overall survival (OS)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

Other Outcomes (1)

• Biomarker analysis

  Up to 2 years

Study Arms (1)

Cadonilimab+S-1or Capecitabine

EXPERIMENTAL

Drug: Cadonilimab+S-1or Capecitabine

Interventions

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.

Cadonilimab+S-1or Capecitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)