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CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer

ConditionLocally Advanced Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Changzheng Hospital

About this trial

This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed rectal adenocarcinoma with cT3+N+M0

Immunohistochemistry and/or genetic testing confirmed pMMR/MSS

Initial diagnosed or recurrent patients will be accepted, patients with recurrence should not have received any treatment include chemotherapy, targeted therapy or immunotherapy within 1 month or radiotherapy within 1 year

Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and haven't received any local treatment.

Disqualifiers

Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.

Uncontrolled active bleeding from the primary tumor or intestinal obstruction.

Contraindications of bevacizumab

Hypersensitivity to other monoclonal antibodies.

Trial design

Design model

Single group

Treatments tested in this trial

  • Capecitabine

    Drug

    Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 3 cycles

  • Oxaliplatin

    Drug

    Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 3cycles

  • Bevacizumab

    Drug

    Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 3 cycles

  • Pembrolizumab

    Drug

    Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 3 cycles

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pembrolizumab+ Bevacizumab + CapeOx as neoadjuvant treatment for 4 cyclesExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

R0 resection rate

Percentage of patients who achieve R0 resection

Time frame
15 weeks
2

Pathological complete response rate

Percentage of patients who achieve pathological complete response (pCR) based on local investigator

Time frame
15 weeks
3

Tumor regression grade (TRG)

Time frame
15 weeks
4

Objective response rate

Percentage of patients who achieve partial response (PR) or complete response (CR)

Time frame
3 years

Secondary outcomes

1

Incidence of Treatment-Related Adverse Events

Number of adverse events

Time frame
Until 30 days after the last treatment
2

Surgical complications

Time frame
Until 90 days after surgery
3

Quality of life score (QoL score)

Assessment of life quality based on EORTC QLQ-C30

Time frame
Until 30 days after the last treatment
4

Event free survival

Measure of time from study treatment to disease progression or death

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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

Shanghai Changzheng Hospital

Lead sponsor

Source ClinicalTrials.gov
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