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Sintilimab Plus Bevacizumab and Chemotherapy in MSS/pMMR Colorectal With no Liver Metastasis

ConditionColorectal Cancer Metastatic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital

About this trial

This is a non-randomized, open-label, single-center clinical trial to evaluate efficacy and safety of sintilimab plus bevacizumab and chemotherapy on treatment in patients with advanced no liver metastatic MSS/pMMR colorectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign written informed consent before implementing any experimental procedures

Over 18 years old

Histologically confirmed as colorectal adenocarcinoma without liver metastasis

At least one measurable lesion (RECIST 1.1)

Disqualifiers

Known presence of active central nervous system (CNS) metastases and/or cancerous meningitis

Microsatellite instability (MSI-H) or loss of expression of DNA mismatch repair genes (dMMR)

Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration

Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A

    Drug

    Sintilimab 200mg Bevacizumab 7.5mg/kg Oxaliplatin 130mg/m2 Capecitabine 1250mg/m2

  • Group B

    Drug

    Sintilimab 200mg Bevacizumab 7.5mg/kg Irinotecan 150mg/m2 Capecitabine 1250mg/m2

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Patients who have not received systematic treatment in the pastExperimental treatment 1 intervention
Group B: Patients who have received first-line systemic treatment in the pastExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression free survival

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

ORR

Objective response rate

Time frame
up to 24 weeks
2

DOR

Duration of response

Time frame
up to 24 weeks
3

DCR

Disease control rate

Time frame
up to 24 weeks
4

OS

Overall survival

Time frame
through study completion, an average of 2 year

Other outcomes

Sponsors and contacts

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

Anhui Provincial Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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