Locally Recurrent Colorectal CancerPhase 2NCT06881537
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Locally Recurrent Colorectal Cancer, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Recurrent Colorectal Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 2028
- 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
- Primary colorectal cancer underwent radical surgery, histologically confirmed as adenocarcinoma and achieved R0 resection, and postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens.
- Based on the imaging and histological examination results, the patient was clinically assessed and diagnosed with locally recurrent colorectal adenocarcinoma.
- The patients did not receive any treatment, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within the past month.
- Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
- 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.
- Intestinal obstruction or uncontrollable active bleeding caused by the tumor requiring urgent treatment.
- Contraindications of Oxaliplatin, Capecitabine, Bevacizumab, and Tislelizumab.
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai
Haiyang Zhou, MD, +86 81885615, haiyang1985_1@aliyun.com
About this study
This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer
- Conditions
- Locally Recurrent Colorectal Cancer
- Being tested
- Capecitabine, Oxaliplatin, Bevacizumab, Tislelizumab
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
TislelizumabDrug
Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment | Experimental | CapeOx: 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; Tislelizumab：Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR)
Measured: 15 weeks
R0 resection rate
Percentage of patients who achieve R0 resection
Measured: 15 weeks
Pathological complete response rate
Percentage of patients who achieve pathological complete response (pCR) based on local investigator
Measured: 15 weeks
Tumor regression grade (TRG)
Measured: 15 weeks
Incidence of Treatment-Related Adverse Events
Number of adverse events
Measured: Until 30 days after the last treatment
Secondary outcomes (6)
Surgical complications
Measured: Until 90 days after surgery
Quality of life score (QoL score)
Assessment of life quality based on EORTC QLQ-C30
Measured: Until 30 days after the last treatment
Event free survival
Measure of time from study treatment to disease progression or death
Measured: Up to 3 years
Disease-free survival
Measure of time from the date of surgery to disease relapse or death
Measured: Up to 3 years
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
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.
- First posted18 Mar 2025
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881537
- Sponsor's protocol ID
- ZHOUHAIYANG4
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06881537
- Acronym / sponsor ID
- ZHOUHAIYANG4
- Conditions
- Locally Recurrent Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: TislelizumabCapeOx: 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; Tislelizumab：Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary colorectal cancer underwent radical surgery, histologically confirmed as adenocarcinoma and achieved R0 resection, and postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens.
- Based on the imaging and histological examination results, the patient was clinically assessed and diagnosed with locally recurrent colorectal adenocarcinoma.
- The patients did not receive any treatment, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within the past month.
- Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
Key exclusion criteria (22 listed)
- Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.
- Intestinal obstruction or uncontrollable active bleeding caused by the tumor requiring urgent treatment.
- Contraindications of Oxaliplatin, Capecitabine, Bevacizumab, and Tislelizumab.
- Hypersensitivity to other monoclonal antibodies.
- Any active, known or suspected autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineCapecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles | Drug | CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment |
| OxaliplatinOxaliplatin is given by intravenous infusion at 130mg / m² on Day 1 every 3 weeks for 4 cycles | Drug | CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment |
| BevacizumabBevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles | Drug | CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment |
| TislelizumabTislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles | Drug | CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment |
Primary outcome
Objective response rate
Time frame: 15 weeks
Percentage of patients who achieve partial response (PR) or complete response (CR)
R0 resection rate
Time frame: 15 weeks
Percentage of patients who achieve R0 resection
Pathological complete response rate
Time frame: 15 weeks
Percentage of patients who achieve pathological complete response (pCR) based on local investigator
Tumor regression grade (TRG)
Time frame: 15 weeks
Incidence of Treatment-Related Adverse Events
Time frame: Until 30 days after the last treatment
Number of adverse events
6 secondary outcomes
Surgical complications
Time frame: Until 90 days after surgery
Quality of life score (QoL score)
Time frame: Until 30 days after the last treatment
Event free survival
Time frame: Up to 3 years
Disease-free survival
Time frame: Up to 3 years
One-year or two-year disease-free survival rate
Time frame: Up to 2 years
One-year or two-year overall survival rate
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Locally Recurrent Colorectal 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. 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?
Contact Haiyang Zhou, MD (+86 81885615, haiyang1985_1@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 15 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.