Health TrialsbyHealthPanel

PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM

ConditionColorectal Cancer Liver Metastasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, any gender.

Pathologically confirmed colorectal adenocarcinoma with liver metastases from colorectal cancer.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

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

  • Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy

    Radiation

    PULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times.

  • Bevacizumab

    Drug

    Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.

  • Capecitabine

    Drug

    Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.

  • Oxaliplatin

    Drug

    Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.

  • Sintilimab

    Drug

    Sintilimab: 200mg, d1, q3w, 6 cycles.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: PULSAR combined with PD-1 Ab and Bevacizumab plus ChemotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free-Survival

Time frame
From enrollment to 36 month

Secondary outcomes

1

Adverse Reactions

Time frame
From enrollment to 36 month
2

Overall Survival (OS)

Time frame
From enrollment to 36 month
3

Objective Response Rate (ORR)

Time frame
From enrollment to 36 month

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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