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

ConditionResectable Gastric or Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 4 treatment groups
Group A: Part 1 cohort 1Experimental treatment 3 interventions
Group B: Part 1 cohort 2Experimental treatment 4 interventions
Group C: Part 2 cohort 1Experimental treatment 4 interventions
Group D: Part 2 cohort 2Experimental treatment 5 interventions

Trial outcomes

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

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

Time frame
Up to approximately 2 years

Secondary outcomes

1

Major pathological response(MPR) rates

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

Time frame
Up to approximately 2 years
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

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

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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