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A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer

ConditionsMetastatic Colorectal Cancer (CRC)mCRC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuazhong University of Science and Technology

About this trial

This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 75 years (inclusive).

Histologically or cytologically confirmed stage Ⅳ primary colorectal cancer.

No more than 5 oligometastatic lesions, with metastases usually limited to one or a few specific organs (e.g., liver, lung, etc.), and the metastatic lesions are deemed suitable for stereotactic body radiation therapy (SBRT) by the investigator.

Failure of at least 2 prior lines of standard therapy (based on fluorouracil, oxaliplatin, irinotecan, bevacizumab, cetuximab).

Disqualifiers

Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4 agents, or other investigational immunotherapeutic agents.

Severe autoimmune diseases, including active inflammatory bowel disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.

Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.

Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab (QL1706)

    Drug

    Dual immune checkpoint inhibitor antibody targeting PD-1 and CTLA-4

  • Fruquintinib

    Drug

    TKI

  • Heterogeneous Radiotherapy

    Radiation

    High-dose radiotherapy (SBRT): 8-10 Gy × 5 fractions, administered every other day (qod), to be completed within 10 days. Low-dose radiotherapy (for other lesions): 2 Gy per fraction, one fraction per lesion.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Iparomlimab and Tuvonralimab plus Fruquintinib plus Heterogeneous RadiotherapyExperimental treatment 3 interventions
Group B: Fruquintinib Administration details: 5 mg, oral administration, once daily, with a schedule of 2 weeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival

Defined as the time from the date of a subject's enrollment to the first occurrence of disease progression or death, whichever comes first.

Time frame
From date of subject's enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

Objective Response Rate (ORR)

Defined as the proportion of patients achieving a confirmed objective tumor response (including complete response \[CR\] and partial response \[PR\]) assessed in accordance with the RECIST v1.1 criteria.

Time frame
1 year
2

Overall Survival (OS)

Defined as the time from the date of a subject's enrollment to death from any cause.

Time frame
From date of subject's enrollment until the date of death from any cause, assessed up to 100 months
3

Disease Control Rate (DCR)

Defined as the percentage of evaluable patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 8 weeks.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Huazhong University of Science and Technology

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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