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NCT Number: NCT05960955

Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Provincial Tumor Hospital

Tianjin, China

Location status: Recruiting

Location contact

Han Liang, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be able and willing to provide written informed consent.
  • 18 to 75 years old.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
  • Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer [AJCC])
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Has adequate organ function.

Exclusion criteria

  • Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
  • Is currently participating in a study of an investigational agent or using an investigational device.
  • Has undergone major surgery within 30 days of Study Day 1.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Has received a live virus vaccine within 30 days of the planned first dose of study therapy.

Treatment and study plan

cadonilimab

Drug

IV infusion,Specified dose on specified days

AK117

Drug

IV infusion,Specified dose on specified days

Oxaliplatin

Drug

IV infusion,Specified dose on specified days

Tegafur-Gimeracil-Oteracil Potassium

Drug

Oral,Specified dose on specified days

docetaxel

Drug

IV infusion,Specified dose on specified days

5-fluorouracil

Drug

IV infusion,Specified dose on specified days

Primary outcomes

  1. Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance

    Time frame: Up to approximately 2 years

  2. Pathological complete response (pCR) rates

    Time frame: Up to approximately 2 years

    pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes

Secondary outcomes

  1. Major pathological response(MPR) rates

    Time frame: Up to approximately 2 years

    MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes

  2. Tumor regression grade(TRG)

    Time frame: Up to approximately 2 years

  3. R0 resection rate

    Time frame: Up to approximately 2 years

  4. Tumor descending stage rate

    Time frame: Up to approximately 2 years

    Proportion of subjects whose tumor TNM stage decreased from baseline before surgery

  5. ORR

    Time frame: Up to approximately 2 years

  6. EFS

    Time frame: Up to approximately 2 years

  7. OS

    Time frame: Up to approximately 2 years

  8. PK

    Time frame: Up to approximately 2 years

    Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points

  9. ADA

    Time frame: Up to approximately 2 years

    Number of subjects with detectable anti-drug antibodies (ADA).

Study contacts

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

Han Liang, MD

CONTACT

Weifeng Song, MD

CONTACT

[email protected]

+86(0760)89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
Nov 18, 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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