Locally Advanced Colorectal CancerPhase 2NCT07819604
Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
A Phase 2 study testing Serplulimab, CAPOX and Bevacizumab in people with Locally Advanced Colorectal Cancer, run by Xijing Hospital.
Trial summary
This is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- Serplulimab, CAPOX and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2030
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent prior to screening.
- Male or female subjects aged ≥18 years.
- At least one measurable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically or pathologically confirmed locally advanced rectal adenocarcinoma, cT3/cT4N+M0 stage per AJCC/UICC 8th edition, with distance from anal verge ≤10 cm. Diagnosis is confirmed by contrast-enhanced CT/MRI, supplemented by colonoscopy and diagnostic laparoscopy if necessary; no prior anti-tumor treatment.
- Scheduled for surgical resection following neoadjuvant therapy based on clinical staging.
Show all 13Show fewer
- Expected survival of more than 3 months.
- No emergency indications such as bowel obstruction, bleeding or perforation.
- Adequate major organ function as follows (no blood transfusion, granulocyte-colony stimulating factor (G-CSF) or other hematopoietic growth factor support within 14 days prior to screening):
- Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L, white blood cell count ≥3.5×10⁹/L.
- Liver function: ALT and AST ≤2.5×ULN; total bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert syndrome).
- Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min.
- Coagulation function: APTT, INR, PT ≤1.5×ULN.
Who cannot join
- Prior anti-tumor therapy including chemotherapy, radiotherapy, hormonal therapy or molecular-targeted therapy.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other agents targeting T-cell co-stimulatory or immune-checkpoint pathways.
- History of other malignant tumors within 5 years or concurrent other malignancies, except for cured carcinoma in situ of cervix, non-melanoma skin cancer, or other malignancies with ≥5 years disease-free survival after curative treatment.
- Peripheral neuropathy ≥Grade 2 per NCI-CTCAE v5.0.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- History of severe hypersensitivity reaction (NCI-CTCAE v5.0 ≥Grade 3) to anti-PD-1 monoclonal antibodies, other monoclonal antibodies, oxaliplatin, S-1 or related compounds.
Show all 26Show fewer
- History of hereditary bleeding disorders or coagulopathy with high bleeding risk.
- Major surgical procedure within 4 weeks prior to screening.
- Not recovered from prior surgical complications with residual toxicity >Grade 1 (NCI-CTCAE v5.0), excluding alopecia and fatigue.
- Requirement for immunosuppressive medication within 2 weeks before screening or during study treatment, except for:
- Intranasal, inhaled, topical or intra-articular corticosteroids.
- Physiological-dose systemic corticosteroids (≤10 mg/day prednisone or equivalent).
- Short-term (≤7 days) corticosteroids for prophylaxis or treatment of non-autoimmune allergic conditions.
- Active or history of recurrent autoimmune disease.
- History of interstitial lung disease or non-infectious pneumonitis.
- Known active tuberculosis (Mycobacterium tuberculosis) infection.
- Human immunodeficiency virus (HIV) positive, other acquired or congenital immunodeficiency, history of organ transplantation or stem-cell transplantation.
- Hepatitis B or C virology findings at screening meeting any of the following:
- HBsAg-positive with HBV-DNA ≥10⁴ copies/mL or ≥2000 IU/mL (antiviral therapy may be administered for HBV carriers at investigator's discretion).
- Active hepatitis C: HCV-antibody-positive with detectable HCV-RNA above assay lower limit.
- Active or uncontrolled infection requiring systemic therapy within 2 weeks prior to screening.
- Receipt of live-virus vaccine within 4 weeks prior to screening.
- Bowel obstruction, or history of inflammatory bowel disease, extensive bowel resection with chronic diarrhea, Crohn's disease, ulcerative colitis or chronic diarrhea.
- Lactating females, or females planning pregnancy during study treatment or within 6 months after treatment completion.
- Subjects (fertile males, females and their male partners) unwilling to use effective contraception during study treatment and for 6 months after treatment completion.
- Any other condition that, in the investigator's opinion, would compromise study compliance or outcome assessment, making the subject unsuitable for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Phase II, Multicenter Study of Serplulimab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
This is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Secondary efficacy endpoints include major pathological response (MPR), R0 resection rate, tumor down-staging, objective response rate (ORR), disease-free survival (DFS), and quality of life, to demonstrate clinical benefit of this combination regimen in the target patient population.
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- Serplulimab, CAPOX, Bevacizumab
- Keywords
- Serplulimab, CAPOX, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Anti-PD-1 monoclonal antibody, administered intravenously as neoadjuvant therapy.
CAPOXDrug
Combination chemotherapy regimen consisting of capecitabine plus oxaliplatin, administered intravenously as neoadjuvant therapy.
BevacizumabDrug
Anti-VEGF monoclonal antibody, administered intravenously as neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment | Experimental | Not described Receives: Drug: Serplulimab; Drug: CAPOX; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Percentage of patients who achieve pathological complete response, defined as no residual viable tumor cells in the resected surgical specimen.
Measured: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Secondary outcomes (5)
Major Pathological Response (MPR) Rate
Percentage of patients with ≤10% residual viable tumor cells in the resected surgical specimen.
Measured: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
R0 Resection Rate
Proportion of patients who undergo complete R0 surgical resection.
Measured: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Tumor Down-staging Rate
Proportion of patients with pathological tumor down-staging compared with baseline clinical staging.
Measured: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Objective Response Rate (ORR)
Proportion of patients with complete or partial response assessed by imaging according to RECIST criteria.
Measured: Up to 6 weeks after completion of neoadjuvant therapy (prior to surgical resection)
Disease-Free Survival (DFS)
Time from randomization/surgery to disease recurrence or death from any cause.
Measured: Up to 36 months after surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (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.
- More trials run by Xijing 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Hong, Principal investigator, Xijing Hospital of Digestive Diseases, Xijing Hospital, Air force Medical University, Changlexi ST 15, Shaanxi Province, 710032, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819604
- Sponsor's protocol ID
- XJYY-LL-FJ-030
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II, Multicenter Study of Serplulimab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07819604
- Acronym / sponsor ID
- XJYY-LL-FJ-030
- Conditions
- Locally Advanced Colorectal Cancer
- Keywords
- Serplulimab, CAPOX, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 15 Sep 2026 (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 is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Secondary efficacy endpoints include major pathological response (MPR), R0 resection rate, tumor down-staging, objective response rate (ORR), disease-free survival (DFS), and quality of life, to demonstrate clinical benefit of this combination regimen in the target patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment | Experimental | Drug: Serplulimab, Drug: CAPOX, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily provide written informed consent prior to screening.
- Male or female subjects aged ≥18 years.
- At least one measurable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically or pathologically confirmed locally advanced rectal adenocarcinoma, cT3/cT4N+M0 stage per AJCC/UICC 8th edition, with distance from anal verge ≤10 cm. Diagnosis is confirmed by contrast-enhanced CT/MRI, supplemented by colonoscopy and diagnostic laparoscopy if necessary; no prior anti-tumor treatment.
Key exclusion criteria (26 listed)
- Prior anti-tumor therapy including chemotherapy, radiotherapy, hormonal therapy or molecular-targeted therapy.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other agents targeting T-cell co-stimulatory or immune-checkpoint pathways.
- History of other malignant tumors within 5 years or concurrent other malignancies, except for cured carcinoma in situ of cervix, non-melanoma skin cancer, or other malignancies with ≥5 years disease-free survival after curative treatment.
- Peripheral neuropathy ≥Grade 2 per NCI-CTCAE v5.0.
- Known active central nervous system metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| SerplulimabAnti-PD-1 monoclonal antibody, administered intravenously as neoadjuvant therapy. | Drug | Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment |
| CAPOXCombination chemotherapy regimen consisting of capecitabine plus oxaliplatin, administered intravenously as neoadjuvant therapy. | Drug | Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment |
| BevacizumabAnti-VEGF monoclonal antibody, administered intravenously as neoadjuvant therapy. | Drug | Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Percentage of patients who achieve pathological complete response, defined as no residual viable tumor cells in the resected surgical specimen.
5 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
R0 Resection Rate
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Tumor Down-staging Rate
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)
Objective Response Rate (ORR)
Time frame: Up to 6 weeks after completion of neoadjuvant therapy (prior to surgical resection)
Disease-Free Survival (DFS)
Time frame: Up to 36 months after surgical resection
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 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
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.
Liu Hong principal investigator
Xijing Hospital of Digestive Diseases, Xijing Hospital, Air force Medical University, Changlexi ST 15, Shaanxi Province, 710032, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, CAPOX and Bevacizumab in people with Locally Advanced Colorectal Cancer, run by Xijing Hospital.
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 13 inclusion and 26 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jinqiang Liu (19929061886, ljq679@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)). 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 15 Sep 2026.