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Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLiu Huang

About this trial

An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age = 18 years, $75 years

Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer

MSI status: MSS

At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities

Disqualifiers

• Patients have received anti-PD-1 / PD-L1 or anti-CTLA-4 immunotherapy or other immunexperimental drugs

Patients with severe autoimmune diseases: active inflammatory bowel disease (including Cohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus ervthematosus, autoimmune vasculitis (such as Wegener's granuloma), etc

Symptomatic interstitial lung disease or active infection/non-infectious pneumonia

Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fruquintinib

    Drug

    Fruquintinib:5mg ,qd,po, d1-d14, q3w

  • Cadonilimab

    Drug

    Cadonilimab:10mg/kg, ivgtt, d1, q3w

  • SBRT

    Radiation

    SBRT:8-10Gy×5F, god, in 10 days

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: fuquintinibPlacebo comparator 1 intervention
Group B: Fuquintinib combined with cardonilizumab and SBRTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

6-month progression-free survival in patients with third-line and postline metastatic colorectal cancer mCRC with cardonilizumab combined with fuquinitinib and SBRT compared with fuquinitinib monotherapy (6mon-PFS)

Time frame
6mon-PFS

Secondary outcomes

1

Obiective response rate (ORR)

CR + PR rate according to the RECIST version 1.1 guidelines.

Time frame
up to 42 months]
2

Disease control rate (DCR)

Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.

Time frame
up to 42 months]
3

Overall survival (OS)

The time interval between the start date of study drug and the date of death (any cause)

Time frame
up to 42 months]
4

quality of life (QOL)

OOL according to OOL-C30

Time frame
up to 42 months]

Other outcomes

Sponsors and contacts

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

Liu Huang

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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