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Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer

ConditionsColorectal Cancer MetastaticChemotherapyTargeted TherapyImmunotherapyRadiotherapy, Intensity-Modulated
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with advanced colorectal adenocarcinoma of MSS/pMMR confirmed by histologic or cytologic diagnosis;

aged 18 years and older;

have a quality of life score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG);

can take oral medications;

Disqualifiers

prior application of trefluridine tepidopyrimidine;

prior application of PD-1 or PD-L1 monoclonal antibody;

extensive bone metastases;

extensive peritoneal metastases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trifluorouracil tepidopyrimidine

    Drug

    30mg/m2. P.O. bid. d1-d5 and d15-d19. q4w

  • Bevacizumab

    Drug

    5mg/kg. ivgtt. d1 and d15. q4w

  • Sindilizumab

    Drug

    200mg. ivgtt. d1. q4w

  • IMRT

    Radiation

    In terms of obstruction, bleeding, compression, or pain due to a tumor that requires local treatment. IMRT was delivered to the involved lesions.

Treatment groups

57 Participants
are divided into 2 treatment groups
Group A: three-drug combinationExperimental treatment 3 interventions
Group B: three-drug combination and radiotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) was defined as the percentage of CR+PR among the patients who could be evaluated for efficacy.

Time frame
Baseline, 6-8 weeks after treatment complete

Secondary outcomes

1

Disease control rate (DCR)

Disease control rate (DCR) was defined as the percentage of CR+PR+SD among the patients who could be evaluated for efficacy.

Time frame
Baseline, 6-8 weeks after treatment complete
2

Progression-free survival (PFS)

Progression-free survival (PFS) was calculated from the date of treatment to either the date of disease progression, death or last follow-up.

Time frame
month 6, year 1, year 2
3

Overall survival (OS)

Overall survival (OS) was calculated from the date of treatment to either the date of death or last follow-up.

Time frame
month 6, year 1, year 2
4

Treatment related toxicity

Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Time frame
Baseline, 6-8 weeks after treatment complete

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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