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Locally Advanced Rectal CancerPhase 2COBPNCT05585814

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

A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Locally Advanced Rectal Cancer, run by Shanghai Changzheng Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
Capecitabine, Oxaliplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2023to 9 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Absence of distant metastasis confirmed by CT, MRI or PET/CT
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  • Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. Absolute neutrophil count ≥1500/mm3, platelet ≥100,000/mm3, Hb ≥10g/dl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL/min, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment).
  • Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days.
  • Life expectancy> 3 months
  • Signed and written informed consent

Who cannot join

  • 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.
  • Any active, known or suspected autoimmune disease.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites to a moderate or greater extent.
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  • History of one of the following diseases: idiopathic pulmonary fibrosis, organized pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia and interstitial pneumonia, or evidence of active pneumonia through enhanced chest CT screening.
  • Major surgery within 4 weeks before enrollment and haven't fully recovered from the previous surgery.
  • Active bleeding or abnormal coagulation (aPTT >43s or INR >1.5 times ULN), or having a tendency to bleed or receiving thrombolytic or anticoagulant therapy.
  • Previously received allogeneic stem cell or parenchymal organ transplantation.
  • Any significant clinical or laboratory abnormality that the investigator considers to influence the safety assessment, eg. uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to normal range with monotherapy, grade II or above peripheral neuropathy, congestive heart failure, heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, unstable angina pectinis, chronic kidney disease, abnormal thyroid function and previous or co-existing malignancies.
  • History of uncorrected serum electrolyte disturbances such as potassium, calcium and magnesium.
  • HIV infection.
  • Active hepatitis B or hepatitis C.
  • Pregnancy or lactation period, or unwilling to use contraception during the trial.
  • With other malignancy within 5 year, except cervical carcinoma in situ, basal or squamous skin cancer, local prostatic carcinoma and ductal carcinoma in situ.
  • Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment.
  • Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year.
  • Active infection, or treatment with oral or intravenous antibiotics within the first 2 weeks prior to neoadjuvant therapy, except prophylactic administration.
  • Anti-infective vaccine (eg. influenza vaccine, varicella vaccine, etc.) injection within 4 weeks before neoadjuvant therapy.
  • Previous participation in other clinical trials within 4 weeks before neoadjuvant therapy.
  • Any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory results that may constrain the use of trial drug, or affect the reliability of study results, or lead to high risk of treatment complications, or affect patient compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Changzheng Hospital

    Shanghai

Other trials in China

About this study

Official title: CapeOX Combined With Bevacizumab Plus Pembrolizumab as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer (COBP)

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles

  • OxaliplatinDrug

    Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 4 cycles

  • BevacizumabDrug

    Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles

  • PembrolizumabDrug

    Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

Study groups in NCT05585814
Study groupRoleWhat they receive
Pembrolizumab+ Bevacizumab + CapeOx as neoadjuvant treatment for 4 cyclesExperimentalCapeOx: Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 4 cycles; Bevacizumab：Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles; Pembrolizumab：Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles. Following these 4 cycles, patients receive one additional 21-day bridging cycle of CapeOx (Capecitabine plus Oxaliplatin) before surgery.
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 resection rate

    Percentage of patients who achieve R0 resection

    Measured: 15 weeks

  2. Pathological complete response rate

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

    Measured: 15 weeks

  3. Tumor regression grade (TRG)

    Measured: 15 weeks

  4. Objective response rate

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

    Measured: 3 years

Secondary outcomes (7)

  1. Incidence of Treatment-Related Adverse Events

    Number of adverse events

    Measured: Until 30 days after the last treatment

  2. Surgical complications

    Measured: Until 90 days after surgery

  3. Quality of life score (QoL score)

    Assessment of life quality based on EORTC QLQ-C30

    Measured: Until 30 days after the last treatment

  4. Event free survival

    Measure of time from study treatment to disease progression or death

    Measured: Up to 3 years

  5. Disease-free survival

    Measure of time from the date of surgery to disease relapse or death

    Measured: Up to 3 years

  6. One-year or two-year disease-free survival rate

    Percentage of patients who achieve disease-free survival lasting for more than one and two years respectively from the date of surgery

    Measured: Up to 2 years

  7. One-year or two-year overall survival rate

    Percentage of patients who achieve survival for more than one and two years respectively from date of first dose

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start1 May 2023
  3. Primary completion18 Sep 2024
  4. Study completion9 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585814
Sponsor's protocol ID
ZHOUHAIYANG
Acronym
COBP
Status last verified
Aug 2026
First submitted
9 Oct 2022
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to patient privacy and institutional data-protection requirements

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Locally Advanced Rectal Cancer, run by Shanghai Changzheng Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: 15 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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