Locally Advanced Rectal CancerNCT07854964
A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer
A study testing Serplulimab, Bevacizumab and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Tang-Du Hospital.
Trial summary
The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer. 1. What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ? 2. 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?
- Serplulimab, Bevacizumab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 May 2031
- Phase
- Interventional
- 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
- 1. Written informed consent must be signed before any trial-related procedures are performed.
- 2. Male or female, aged ≥18 years and ≤75 years.
- 3. Histologically or pathologically confirmed rectal adenocarcinoma, with confirmed proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; diagnosed as locally advanced rectal cancer according to AJCC 9th edition, with cTNM staging as cT2-4N1-3M0 based on contrast-enhanced CT/MRI, and the lesion assessed as resectable by the investigator.
- 4. No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
- 5. ECOG performance status 0-1.
- 6. Expected survival >6 months.
Show all 17Show fewer
- 7. Adequate organ function, meeting the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥1.5×10^9/L without granulocyte colony-stimulating factor support within the past 14 days;
- Platelet count ≥100×10^9/L without blood transfusion within the past 14 days;
- Hemoglobin >9 g/dL without blood transfusion or erythropoietin use within the past 14 days;
- Total bilirubin ≤1.5× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN;
- Serum creatinine ≤1.5× ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL/min;
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or free T3) and free T4 within the normal range may also be enrolled;
- Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive judgment are also allowed for enrollment).
- 8. For female patients who are not postmenopausal or surgically sterile: abstinence or use of effective contraceptive methods during the treatment period and for at least 7 months after the last dose of study treatment.
Who cannot join
- 1.Known squamous cell carcinoma, undifferentiated carcinoma, or other histologic types of colorectal cancer, or adenocarcinoma mixed with other histologic types.
- 2.Known deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status.
- 3.Presence of unresectable factors, including unresectability due to tumor-related reasons, presence of surgical contraindications, or subject refusal to undergo surgery.
- 4.Diagnosis of another malignancy other than colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- 5.Current participation in interventional clinical research treatment, or receipt of another investigational drug or use of an investigational device within 4 weeks prior to the first dose.
- 6.Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment directed at tumor immuno-mechanisms.
Show all 12Show fewer
- 7.Severe cardiac disease or conditions, including but not limited to: a confirmed history of heart failure or systolic dysfunction (LVEF <50%); uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block).
- 8.Poorly controlled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg).
- 9.Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.
- 10.Known hypersensitivity to any component of the study drug regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- 11.Female patients who are pregnant, breastfeeding, or of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential who are unwilling to use effective contraceptive methods throughout the trial and for at least 7 months after the last dose of study treatment.
- 12.Presence of serious concomitant disease or other confounding conditions that would interfere with planned treatment, or any other condition that, in the investigator's opinion, makes 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.
Nan Wang contact
About this study
Official title: A Prospective, Single-center, Phase II Study of Serplulimab Combined With XELOX and Bevacizumab Neoadjuvant Therapy for Locally Advanced Rectal Cancer
The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer.
- What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ?
- What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed.
Read more
Participates will
- The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks).
- Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy.
- Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy.
- Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent.
- Pathological assessment
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Serplulimab, Bevacizumab, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Intravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment
BevacizumabDrug
Intravenous infusion, 7.5 mg/kg, Day 1 of every 3-week cycle, neoadjuvant treatment
OxaliplatinDrug
Intravenous infusion, 130 mg/m², Day 1 of every 3-week cycle, XELOX regimen
CapecitabineDrug
Oral administration, 1000 mg/m² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Serplulimab combined with bevacizumab plus XELOX (oxaliplatin + capecitabine) as neoadjuvant therapy for locally advanced rectal cancer Receives: Drug: Serplulimab; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
The pCR rate and its 95 % confidence interval were calculated
Measured: At the time of surgical resection, 4 to 6 weeks after completion of neoadjuvant therapy'
Secondary outcomes (5)
safety analysis
The incidence of adverse events and its 95 % confidence interval were calculated. Adverse events were summarized according to the classification of system organs.
Measured: From first study drug administration through 30 days after surgery
Analysis of objective remission rate
ORR and its 95 % confidence interval were calculated
Measured: Up to 6 weeks after completion of neoadjuvant therapy, prior to surgery
R0 resection rate analysis
The R0 resection rate and its 95 % confidence interval were calculated
Measured: On the day of surgery
Analysis of anal preservation rate
The anal sphincter preservation rate and its 95 % confidence interval were calculated
Measured: On the day of surgery
MMR / MSI status and PD-L1 expression level
The correlation between biomarkers such as MMR / MSI status and PD-L1 expression level and treatment response was analyzed
Measured: Two weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 May 2030 (estimated)
- Study completion15 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Nan, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854964
- Sponsor's protocol ID
- WN-K202603-16
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Phase II Study of Serplulimab Combined With XELOX and Bevacizumab Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07854964
- Acronym / sponsor ID
- WN-K202603-16
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 15 May 2031 (estimated)
- First posted
- 2 Oct 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.
The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer.
- What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ?
- What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed.
Participates will
- The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks).
- Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy.
- Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy.
- Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent.
- Pathological assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Serplulimab, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: CapecitabineSerplulimab combined with bevacizumab plus XELOX (oxaliplatin + capecitabine) as neoadjuvant therapy for locally advanced rectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1. Written informed consent must be signed before any trial-related procedures are performed.
- 2. Male or female, aged ≥18 years and ≤75 years.
- 3. Histologically or pathologically confirmed rectal adenocarcinoma, with confirmed proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; diagnosed as locally advanced rectal cancer according to AJCC 9th edition, with cTNM staging as cT2-4N1-3M0 based on contrast-enhanced CT/MRI, and the lesion assessed as resectable by the investigator.
- 4. No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
- 5. ECOG performance status 0-1.
Key exclusion criteria (12 listed)
- 1.Known squamous cell carcinoma, undifferentiated carcinoma, or other histologic types of colorectal cancer, or adenocarcinoma mixed with other histologic types.
- 2.Known deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status.
- 3.Presence of unresectable factors, including unresectability due to tumor-related reasons, presence of surgical contraindications, or subject refusal to undergo surgery.
- 4.Diagnosis of another malignancy other than colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- 5.Current participation in interventional clinical research treatment, or receipt of another investigational drug or use of an investigational device within 4 weeks prior to the first dose.
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 |
|---|---|---|
| SerplulimabIntravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment | Drug | Intervention group |
| BevacizumabIntravenous infusion, 7.5 mg/kg, Day 1 of every 3-week cycle, neoadjuvant treatment | Drug | Intervention group |
| OxaliplatinIntravenous infusion, 130 mg/m², Day 1 of every 3-week cycle, XELOX regimen | Drug | Intervention group |
| CapecitabineOral administration, 1000 mg/m² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen | Drug | Intervention group |
Primary outcome
pCR rate
Time frame: At the time of surgical resection, 4 to 6 weeks after completion of neoadjuvant therapy'
The pCR rate and its 95 % confidence interval were calculated
5 secondary outcomes
safety analysis
Time frame: From first study drug administration through 30 days after surgery
Analysis of objective remission rate
Time frame: Up to 6 weeks after completion of neoadjuvant therapy, prior to surgery
R0 resection rate analysis
Time frame: On the day of surgery
Analysis of anal preservation rate
Time frame: On the day of surgery
MMR / MSI status and PD-L1 expression level
Time frame: Two weeks after operation
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 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Rectal Cancer
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-)
RecruitingPhase 2
Isunakinra Alone and in Combination With Pembrolizumab in Patients With Colorectal Cancer (MSS)
Colorectal Cancer Metastatic
Active, not recruitingPhase 1/2
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
RecruitingPhase 3
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
Locally Advanced Rectal Carcinoma
Active, not recruitingPhase 2
Induction Chemotherapy for Locally Advanced Rectal Cancer
Rectal Cancer
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.
Nan Wang contact
Questions about this trial
What is this clinical trial studying?
A study testing Serplulimab, Bevacizumab and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Tang-Du 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 17 inclusion and 12 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 13 Oct 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.
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 Nan Wang, Ph.D (02984777431, wangnandoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: At the time of surgical resection, 4 to 6 weeks after completion of neoadjuvant therapy'). 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 13 Oct 2026.