Locally Advanced Colorectal CancerPhase 4NCT06550453
Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer
A Phase 4 study testing Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) in people with Locally Advanced Colorectal Cancer, run by yangjianjun at 1 site in China.
Trial summary
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 15 Jan 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years;
- Confirmed RAS mutation and BRAF wild-type in LACRC by pathological histology or genetic sequencing.;
- ECOG Performance Status (PS) score of 0 or 1;
- Previously untreated;
- Microsatellite-stable status;
- Hematological parameters within normal limits: White blood cell count ≥4×10^9/L; Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L. Hemoglobin ≥90g/L;
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- Normal renal function: Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance (CrCl) >60 mL/min (calculated using Cockcroft-Gault formula): Female CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl)；Male CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl);
- Normal liver function: Serum total bilirubin ≤1.5× ULN; Aspartate aminotransferase (AST) ≤2.5× ULN; Alanine aminotransferase (ALT) ≤2.5× ULN;
- Female patients must have a negative pregnancy test before the study initiation (not applicable to bilateral oophorectomy and/or hysterectomy patients or postmenopausal patients);
- Signed written informed consent form.
Who cannot join
- Receiving anti-tumor therapy prior to enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKI, and anti-angiogenic drugs;
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, desiccation syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease, psoriasis not requiring systemic therapy, or patients not expected to have a relapse without external triggers may be allowed to enroll);
- Enrolled in another interventional clinical trial within 30 days prior to screening;
- History of other malignancies (except cured basal cell carcinoma of the skin);
- Presence of severe, poorly controlled co-morbidities such as heart failure, diabetes mellitus, hypertension, hepatic failure, renal failure, thyroid disease, psychiatric disorders, etc;
- Known HIV infection or active viral hepatitis or tuberculosis;
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- Major surgery or planned surgery within 30 days prior to the first dose of the investigational drug;
- Hypersensitivity to the drugs used in the trial or their components;
- Pregnancy (confirmed by blood or urine HCG test) or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception until at least 6 months after the last trial treatment;
- Deemed inappropriate for participation in the study by the investigator.
- Unwilling or unable to participate in the study or sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Shu Wang contact
China1 site, 1 recruiting
- Recruiting
the First Affliated Hospital (Xijing Hospital),the First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jianjun Yang, yangjj@fmmu.edu.cn
About this study
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer.
Methods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)
- Keywords
- Locally advanced colorectal cancer (LACRC), pembrolizumab, microsatellite-stabilized, CapeOX neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)Drug
Pabolizumab is an lgG4 subclass monoclonal antibody humanized against PD-l molecules thatblocks the immune escape mechanism of cancer cells by inhibiting the PD-l receptor oflymphocytes, thereby allowing the immune system to destroy them.
In the single-arm study, all enrolled patients received a combination of chemotherapy and immunotherapy, as outlined below:
Pembrolizumab:
Day 1：Pembrolizumab injection 200mg was administered once and repeated every 21 days, expected to last 2-4 cycles. Two vials (200 mg) of pembrolizumab injection should be diluted into 100-200 mL of saline, and the infusion time should be more than 30 minutes.
Chemotherapy (CapeOX regimen):
Day 2: Bevacizumab (7.5 mg/kg) + Oxaliplatin (135 mg/m2) + Capecitabine (1 g/m2, did, d1-d14). Treatment repeated every 3 weeks (q3w) until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) | Experimental | all enrolled patients received a combination of chemotherapy and immunotherapy, as outlined below:
Pembrolizumab:
Day 1：Pembrolizumab injection 200mg was administered once and repeated every 21 days, expected to last 2-4 cycles. Two vials (200 mg) of pembrolizumab injection should be diluted into 100-200 mL of saline, and the infusion time should be more than 30 minutes.
Chemotherapy (CapeOX regimen):
Day 2: Bevacizumab (7.5 mg/kg) + Oxaliplatin (135 mg/m2) + Capecitabine (1 g/m2, did, d1-d14). Treatment repeated every 3 weeks (q3w) until disease progression or intolerable toxicity. Receives: Drug: Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Pathological complete reand the postoperative pathological findings were statistically completse rate (pCR rate): The pathological status of the primary site was determined in the surgical patient Proportion of patients with complete response:
Measured: 12 months
Secondary outcomes (3)
Objective response rate (ORR) in the neoadjuvant phase
Obiective response rate (ORR) at the neadjuvant stage: proportion of subjects who achieved partiaand complete response on radiographic assessment (RECIST v1.l) after the end of neoadjuvanttherapy;
Measured: 36 months
Major pathological response rate (MPR)
Major pathological response rate (MPR rate): The pathological status of the primary site wadetermined in the patients undergoing surgery, and the proportion of patients with residuatumor cells <10% by pathological detection in postoperative specimens was counted
Measured: 36 months
Adverse event rate (AE)
Safety: all adverse events, serious adverse events;
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yangjianjun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yangjianjun, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550453
- Sponsor's protocol ID
- KY20232402
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06550453
- Acronym / sponsor ID
- KY20232402
- Conditions
- Locally Advanced Colorectal Cancer
- Keywords
- Locally advanced colorectal cancer (LACRC), pembrolizumab, microsatellite-stabilized, CapeOX neoadjuvant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- yangjianjunUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 13 Aug 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.
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer.
Methods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) | Experimental | Drug: Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)all enrolled patients received a combination of chemotherapy and immunotherapy, as outlined below: Pembrolizumab: Day 1：Pembrolizumab injection 200mg was administered once and repeated every 21 days, expected to last 2-4 cycles. Two vials (200 mg) of pembrolizumab injection should be diluted into 100-200 mL of saline, and the infusion time should be more than 30 minutes. Chemotherapy (CapeOX regimen): Day 2: Bevacizumab (7.5 mg/kg) + Oxaliplatin (135 mg/m2) + Capecitabine (1 g/m2, did, d1-d14). Treatment repeated every 3 weeks (q3w) until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: ≥18 years;
- Confirmed RAS mutation and BRAF wild-type in LACRC by pathological histology or genetic sequencing.;
- ECOG Performance Status (PS) score of 0 or 1;
- Previously untreated;
- Microsatellite-stable status;
Key exclusion criteria (11 listed)
- Receiving anti-tumor therapy prior to enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKI, and anti-angiogenic drugs;
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, desiccation syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease, psoriasis not requiring systemic therapy, or patients not expected to have a relapse without external triggers may be allowed to enroll);
- Enrolled in another interventional clinical trial within 30 days prior to screening;
- History of other malignancies (except cured basal cell carcinoma of the skin);
- Presence of severe, poorly controlled co-morbidities such as heart failure, diabetes mellitus, hypertension, hepatic failure, renal failure, thyroid disease, psychiatric disorders, etc;
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 |
|---|---|---|
| Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)Pabolizumab is an lgG4 subclass monoclonal antibody humanized against PD-l molecules thatblocks the immune escape mechanism of cancer cells by inhibiting the PD-l receptor oflymphocytes, thereby allowing the immune system to destroy them. In the single-arm study, all enrolled patients received a combination of chemotherapy and immunotherapy, as outlined below: Pembrolizumab: Day 1：Pembrolizumab injection 200mg was administered once and repeated every 21 days, expected to last 2-4 cycles. Two vials (200 mg) of pembrolizumab injection should be diluted into 100-200 mL of saline, and the infusion time should be more than 30 minutes. Chemotherapy (CapeOX regimen): Day 2: Bevacizumab (7.5 mg/kg) + Oxaliplatin (135 mg/m2) + Capecitabine (1 g/m2, did, d1-d14). Treatment repeated every 3 weeks (q3w) until disease progression or intolerable toxicity. | Drug | pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) |
Primary outcome
Pathological complete response rate (pCR)
Time frame: 12 months
Pathological complete reand the postoperative pathological findings were statistically completse rate (pCR rate): The pathological status of the primary site was determined in the surgical patient Proportion of patients with complete response:
3 secondary outcomes
Objective response rate (ORR) in the neoadjuvant phase
Time frame: 36 months
Major pathological response rate (MPR)
Time frame: 36 months
Adverse event rate (AE)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Shu Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) in people with Locally Advanced Colorectal Cancer, run by yangjianjun 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 11 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 12 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jianjun Yang, Professor (86-02984771531, yangjj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: 12 months). 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 12 Nov 2024.