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Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM

ConditionCRC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJin-hong Chen

About this trial

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old and < 75 years old;

ECOG Performance status score 0 or 1;

Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases;

At least one measurable lesion as defined by RECIST version 1.1;

Disqualifiers

Women who are pregnant or breastfeeding;

Patients who have previously been treated with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or other immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or any cellular immunotherapy;

Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;

Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);

Trial design

Design model

Single group

Treatments tested in this trial

  • Candonilimab (AK104)

    Drug

    Cadonilimab (AK104): 6mg/kg, i.v. q2w.

  • Regorafenib

    Drug

    Regorafenib: 80 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Treatment armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Time frame
6 months

Secondary outcomes

1

Disease Control Rate (DCR)

DCR, determined using RECIST v1.1, defined as the percentage of subjects whose best response was not PD (= total number of CR + PR + SD; CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

Time frame
6 months
2

Duration of response (DoR)

DoR, determined using RECIST v1.1, defined as the time from the first judgment of CR or PR to the discovery of PD after treatment.

Time frame
6 months
3

Progression-free Survival (PFS)

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
6 months
4

Overall survival (OS)

OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Jin-hong Chen

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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