Colorectal CancerPhase 2NCT06206096
PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC
A Phase 2 study testing oxaliplatin+capecitabine+bevacizumab+PD-1 antibody in people with Colorectal Cancer and RAS Mutation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, RAS Mutation, Colorectal Neoplasms
- What is being tested?
- oxaliplatin+capecitabine+bevacizumab+PD-1 antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 or cytologically confirmed non resectable, locally advanced or metastatic colorectal cancer;
- No previous anti-tumor treatment for metastatic diseases;
- KRAS/NRAS mutation;
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 3 months;
- Adequate organ and bone marrow functions:
- Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin<1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)<1.5x ULN; Serum creatinine<1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
- Women of childbearing age need to take effective contraceptive measures.
Who cannot join
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
- With BRAF mutation or MSI-H status;
- Other untreated or concurrent tumors (except cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumor, or if the tumor is cured and there is no evidence of disease for more than 3 years);
- Have received other systemic anti-tumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy within 4 weeks before enrollment;
- There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
- Have received any surgery or invasive treatment or operation within 4 weeks before enrollment;
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- Have received Local anti-tumor therapy such as hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation within 4 weeks before enrollment;
- Uncontrolled malignant ascites;
- Participated in other clinical trials within 4 weeks before enrollment, and received corresponding experimental drug treatment;
- Allergic to the study drug or any of its adjuvants;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN；
- The researchers judged clinically significant electrolyte abnormalities;
- Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg; Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;
- Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;
- History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or >2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m); hepatitis and cirrhosis;
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Guanghai Dai, PhD, 13801232381, daigh301@vip.sina.com
About this study
Official title: PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for Patients With RAS-mutant, Microsatellite Stable, Metastatic Colorectal Cancer: a Prospective, Open-label, Single-arm, Phase II Trial
This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.
- Conditions
- Colorectal Cancer, RAS Mutation, Colorectal Neoplasms, Microsatellite Stable Colorectal Carcinoma
- Being tested
- oxaliplatin+capecitabine+bevacizumab+PD-1 antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin+capecitabine+bevacizumab+PD-1 antibodyDrug
oxaliplatin will be administered once every 3 weeks at a dose of 130 mg/m2; Capecitabine will be taken orally at a dose of 1g/m2 twice daily for continuous oral administration over 14 days; Bevacizumab will be administered intravenously every 3 weeks at a dose of 7.5 mg/kg; PD-1 antibody was given due to different types.
| Study group | Role | What they receive |
|---|---|---|
| CAPOX+BEV+PD-1 | Experimental | Not described Receives: Drug: oxaliplatin+capecitabine+bevacizumab+PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of patients with a confirmed complete response or partial response
Measured: up to 3 years
Secondary outcomes (4)
PFS
The time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first
Measured: up to 3 years
OS
The time from randomization to death from any reason
Measured: up to 3 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Measured: up to 3 years
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start26 May 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
- Investigators
- Guanghai Dai, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206096
- Sponsor's protocol ID
- ZLNK-CRC-01
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Jia R, Si H, Ma Y, Fan M, Zhang N, Liu F, Shi Y, Jia Y, Zhang Y, Han Q, Wang Z, Dai G. Efficacy and safety of sintilimab plus bevacizumab and CAPOX as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer. BMC Cancer. 2025 Mar 7;25(1):422. doi: 10.1186/s12885-025-13794-w.
PubMed 40055652
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for Patients With RAS-mutant, Microsatellite Stable, Metastatic Colorectal Cancer: a Prospective, Open-label, Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT06206096
- Acronym / sponsor ID
- ZLNK-CRC-01
- Conditions
- Colorectal Cancer, RAS Mutation, Colorectal Neoplasms, Microsatellite Stable Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jan 2024 (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 study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic 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 |
|---|---|---|
| CAPOX+BEV+PD-1 | Experimental | Drug: oxaliplatin+capecitabine+bevacizumab+PD-1 antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed non resectable, locally advanced or metastatic colorectal cancer;
- No previous anti-tumor treatment for metastatic diseases;
- KRAS/NRAS mutation;
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 3 months;
Key exclusion criteria (22 listed)
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
- With BRAF mutation or MSI-H status;
- Other untreated or concurrent tumors (except cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumor, or if the tumor is cured and there is no evidence of disease for more than 3 years);
- Have received other systemic anti-tumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy within 4 weeks before enrollment;
- There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
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 |
|---|---|---|
| oxaliplatin+capecitabine+bevacizumab+PD-1 antibodyoxaliplatin will be administered once every 3 weeks at a dose of 130 mg/m2; Capecitabine will be taken orally at a dose of 1g/m2 twice daily for continuous oral administration over 14 days; Bevacizumab will be administered intravenously every 3 weeks at a dose of 7.5 mg/kg; PD-1 antibody was given due to different types. | Drug | CAPOX+BEV+PD-1 |
Primary outcome
ORR
Time frame: up to 3 years
The proportion of patients with a confirmed complete response or partial response
4 secondary outcomes
PFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
DCR
Time frame: up to 3 years
Safety and tolerability by incidence, severity and outcome of adverse events
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 40055652Wang Y, Jia R, Si H, Ma Y, Fan M, Zhang N, Liu F, Shi Y, Jia Y, Zhang Y, Han Q, Wang Z, Dai G. Efficacy and safety of sintilimab plus bevacizumab and CAPOX as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer. BMC Cancer. 2025 Mar 7;25(1):422. doi: 10.1186/s12885-025-13794-w.
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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. This study is not recruiting at the moment.
Guanghai Dai, MD principal investigator
Chinese PLA General Hospital
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 oxaliplatin+capecitabine+bevacizumab+PD-1 antibody in people with Colorectal Cancer and RAS Mutation, run by Chinese PLA General 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 8 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru Jia, MD (+8613811721720, ashleyjr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 years). 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 NCT06206096, which also lists 1 linked publication.
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 30 Apr 2024.