Health TrialsbyHealthPanel

Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

ConditionsKidney CancerRCCRenal Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in this study, willing and able to comply with and sign the informed consent form;

Histologically confirmed clear cell renal cell carcinoma;

Advanced (not suitable for curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC;

Confirmed to have at least one measurable lesion according to RECIST 1.1 criteria;

Disqualifiers

Received any systemic treatment for RCC, unless the investigator can provide evidence that the subject has been randomly assigned to the placebo group;

Central nervous system metastasis;

Active malignant tumor in the past 24 months (except for renal cell carcinoma, skin basal cell carcinoma or squamous cell carcinoma that has been clearly treated, as well as cervical or bladder carcinoma in situ). Participants with a history of localized and low-risk prostate cancer who have received curative treatment and have not had a prostate-specific antigen (PSA) recurrence in the past 5 years may participate in the study;

Received prior radiotherapy within 21 days before the start of study treatment (palliative radiotherapy for bone lesions is allowed, provided it is completed at least 2 weeks before the start of study treatment);

Trial design

Design model

Single group

Treatments tested in this trial

  • Vorolanib

    Drug

    stage Ⅰ：Vorolanib 200mg QD stage Ⅱ：Vorolanib RP2D QD

  • cadonilimab

    Drug

    stageⅠ：cadonilimab 10mg/kg Q3W stageⅡ：cadonilimab 10mg/kg Q3W

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate assessed by RECIST 1.1

ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

Time frame
12 months

Secondary outcomes

1

Progression Free Survival assessed by the investigator

PFS, defined as time from study drug administration to progression or death due to any cause.disease progression (PD) or death due to any reason. Imaging assessment is based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Time frame
24 months
2

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

During the AE reporting period specified in the protocol, collect all AEs (including SAEs) and record them in the CRF form.

Time frame
24 months
3

Overall Survival

OS, defined as the time from study drug administration until the date of death due to any cause.

Time frame
24 months
4

Disease Control Rate

DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors.

Time frame
12 months

Other outcomes

1

Circulating Tumor Cell / circulating tumor DNA

Exploration of biomarkers with potential clinical value for the clearance of circulating tumor cells/DNA

Time frame
It is anticipated that blood tests will be conducted on patients before medication, 42±3 days after medication, and within 7 days following disease progression.

Locations

This trial has no locations.

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: