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SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases

ConditionLocally Advanced Rectal Cancer With Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, any gender.

Pathologically confirmed rectal cancer with liver metastases (stage M1).

Karnofsky Performance Status ≥70.

Adequate organ function, no contraindications to radiotherapy, or immunotherapy.

Disqualifiers

Pregnant or lactating women.

Pathological diagnosis of signet ring cell carcinoma.

History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.

Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.

Trial design

Design model

Single group

Treatments tested in this trial

  • Short course radiotherapy

    Radiation

    CTV 25Gy/5Fx.

  • Capecitabine

    Drug

    1000mg/m2, d1-14，bid, q3w, 2 cycles.

  • Oxaliplatin

    Drug

    130mg/m2, d1, q3w, 2 cycles

  • QL1706

    Drug

    5.0 mg/kg, q3w

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Short course radiotherapy combined with CAPOX and QL1706Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free-Survival

Time frame
from enlrollment to 36month

Secondary outcomes

1

Toxic reaction rate above 3rd degree

Time frame
from enlrollment to 36month
2

relapse-free survival

Time frame
from enlrollment to 36month
3

overall survival

Time frame
from enlrollment to 36month

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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