Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab

ConditionSafety

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Voluntarily sign a written ICF. 2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female. 3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.

Disqualifiers

1. Patients with known MSI-H or dMMR. 2. Patients with BRAF mutations. 3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).

Trial design

Design model

Single group

Treatments tested in this trial

AK104 and cetuximab or bevacizumab and FOLFIRI
Drug
AK104 and cetuximab or bevacizumab and FOLFIRI as the second line

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: AK104 Combined With Chemotherapy and Cetuximab or BevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

objective response rate

The proportion of patients whose tumor volume has decreased by 30% and can be maintained for more than 4 weeks

Time frame

the proportion of lung cancer patients participating in clinical research who, after receiving treatment, achieve a significant reduction in tumor volume

Sponsors and contacts

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

Apply now