Locally Advanced Rectal Cancer (LARC)Phase 2NCT07347951
A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
A Phase 2 study testing Short-course radiotherapy, CAPOX chemotherapy and Targeted therapy with bevacizumab in people with Locally Advanced Rectal Cancer (LARC), run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
In a single-center, prospective, phase II study (ClinicalTrials registration number: [to be filled in]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Short-course radiotherapy, CAPOX chemotherapy and Targeted therapy with bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.
- Aged between 18 and 75 years, with no gender restrictions.
- Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0/+M0, and lymph nodes confined within the mesorectum.
- Histologically diagnosed with rectal adenocarcinoma; genetic testing indicates MSS or MSI-L, or immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins).
- ECOG performance status score of 0-1.
- ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion.
- ⑦ Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.8×10⁹/L, platelet count ≥100×10⁹/L, and hemoglobin ≥100 g/L; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g/L; iv. 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times the upper limit of normal.
- ⑧ Willing to participate in this study voluntarily, sign the informed consent form, and comply with the scheduled outpatient visits and related procedural requirements to complete follow-up.
Who cannot join
- In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.
- Patients with metastases to other sites indicated by preoperative staging.
- Patients with suspicious positive lymph nodes in non-draining areas of the rectum, such as the internal and external iliac lymph nodes, as assessed by preoperative MRI or CT.
- Patients requiring emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal hemorrhage.
- Patients with severe comorbid conditions and an estimated life expectancy of ≤5 years.
- Patients with known allergies to any components in the study.
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- ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for immunosuppressive purposes within 30 days prior to the initiation of study treatment.
- ⑧ Patients who have received any other investigational drug treatment (including immunotherapy) or participated in another interventional clinical trial within 30 days prior to screening.
- ⑨ Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases requiring combined treatment (including psychiatric disorders), and severe laboratory abnormalities.
- ⑩ Patients with congenital or acquired immunodeficiency (such as HIV infection).
- ⑪ Vulnerable populations, including individuals with psychiatric disorders, cognitive impairments, critically ill patients, minors, pregnant women, illiterate individuals, etc.
- ⑫ Other circumstances where, in the investigator's judgment, the patient is deemed unsuitable to participate in the clinical trial.
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
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yifei Pan, Master's Degree in Medicine, 86 13506641535, 13506641535@139.com
About this study
Official title: A Single-Center, Prospective, Phase II Clinical Study to Evaluate the Preliminary Efficacy and Safety of Short-Course Radiotherapy Followed by CAPOX Chemotherapy Combined With Serplulimab and Bevacizumab as Total Neoadjuvant Therapy for MSS-Type, Mid-Low Locally Advanced Rectal Cancer
In a single-center, prospective, phase II study (ClinicalTrials registration number: [to be filled in]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027.
This phase II exploratory study targets patients with locally advanced mid-low MSS/pMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal/anal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Short-course radiotherapy, CAPOX chemotherapy, Targeted therapy with bevacizumab, Serplulimab immunotherapy
- Keywords
- Rectal cancer, MSS, neoadjuvant immunotherapy, neoadjuvant chemoradiotherapy, Target therapy, locally advanced
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Radiotherapy adopts a short-course regimen, with a dose of 5*5 Gy, administered once daily at 5 Gy per session for a total of 5 consecutive days of irradiation. It is recommended to use three-dimensional 3D-CRT or IMRT techniques. The irradiation fields include: (1) high-risk recurrence areas of the primary tumor, such as the tumor/tumor bed, mesorectal region, and presacral region. For middle and low rectal cancers, the target area should also encompass the ischioanal fossa; (2) regional lymphatic drainage areas, including the lymphatic drainage area along the common iliac vessels within the true pelvis, mesorectal region, lymphatic drainage area along the internal iliac vessels, and obturator lymph node region.
CAPOX chemotherapyDrug
Chemotherapy with the CAPOX regimen: Capecitabine tablets are available in strengths of 0.5 g/tablet and 0.15 g/tablet; Oxaliplatin for injection is available in a strength of 0.1 g. The chemotherapy protocol is as follows: After a 7-day rest following radiotherapy, on Day 1 (D1), oxaliplatin is administered intravenously at a dose of 130 mg/m² over 2 hours; from Day 1 to Day 14 of each 3-week cycle, capecitabine is taken orally at a dose of 1000 mg/m² twice daily, with each cycle lasting 3 weeks.
Targeted therapy with bevacizumabDrug
Targeted therapy: On Day 1 (D1) of chemotherapy initiation, bevacizumab will be administered via infusion at a dose of 7.5 mg/kg, with each treatment course lasting 3 weeks, for a total of 6 courses.
Serplulimab immunotherapyDrug
Immunotherapy: On Day 1 (D1) of chemotherapy initiation, administer 300 mg of serplulimab, with each treatment cycle lasting 3 weeks, for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC | Experimental | Not described Receives: Radiation: Short-course radiotherapy; Drug: CAPOX chemotherapy; Drug: Targeted therapy with bevacizumab; Drug: Serplulimab immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
In tumor specimens obtained from modified neoadjuvant chemoradiotherapy combined with immunotherapy followed by TME surgical resection, no cancer cells or local lymph node metastasis of cancer cells (ypT0N0M0) are observed under a microscope.
Measured: After the completion of these cycles, surgical treatment will be scheduled as appropriate (within 1-2 weeks) based on the assessment results. Pathological evaluation of the postoperative specimens will be conducted according to the tumor TRG criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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 Rectal Cancer (LARC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Yifei, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347951
- Sponsor's protocol ID
- KY2025-443
- Status last verified
- Oct 2025
- First submitted
- 26 Dec 2025
- Last updated
- 16 Jan 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Phase II Clinical Study to Evaluate the Preliminary Efficacy and Safety of Short-Course Radiotherapy Followed by CAPOX Chemotherapy Combined With Serplulimab and Bevacizumab as Total Neoadjuvant Therapy for MSS-Type, Mid-Low Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07347951
- Acronym / sponsor ID
- KY2025-443
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- Rectal cancer, MSS, neoadjuvant immunotherapy, neoadjuvant chemoradiotherapy, Target therapy, locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 16 Jan 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.
In a single-center, prospective, phase II study (ClinicalTrials registration number: [to be filled in]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027.
This phase II exploratory study targets patients with locally advanced mid-low MSS/pMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal/anal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC | Experimental | Radiation: Short-course radiotherapy, Drug: CAPOX chemotherapy, Drug: Targeted therapy with bevacizumab, Drug: Serplulimab immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.
- ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion.
- ⑦ Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.8×10⁹/L, platelet count ≥100×10⁹/L, and hemoglobin ≥100 g/L; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g/L; iv. 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times the upper limit of normal.
- ⑧ Willing to participate in this study voluntarily, sign the informed consent form, and comply with the scheduled outpatient visits and related procedural requirements to complete follow-up.
Key exclusion criteria (12 listed)
- In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.
- ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for immunosuppressive purposes within 30 days prior to the initiation of study treatment.
- ⑧ Patients who have received any other investigational drug treatment (including immunotherapy) or participated in another interventional clinical trial within 30 days prior to screening.
- ⑨ Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases requiring combined treatment (including psychiatric disorders), and severe laboratory abnormalities.
- ⑩ Patients with congenital or acquired immunodeficiency (such as HIV infection).
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 |
|---|---|---|
| Short-course radiotherapyRadiotherapy adopts a short-course regimen, with a dose of 5*5 Gy, administered once daily at 5 Gy per session for a total of 5 consecutive days of irradiation. It is recommended to use three-dimensional 3D-CRT or IMRT techniques. The irradiation fields include: (1) high-risk recurrence areas of the primary tumor, such as the tumor/tumor bed, mesorectal region, and presacral region. For middle and low rectal cancers, the target area should also encompass the ischioanal fossa; (2) regional lymphatic drainage areas, including the lymphatic drainage area along the common iliac vessels within the true pelvis, mesorectal region, lymphatic drainage area along the internal iliac vessels, and obturator lymph node region. | Radiation | Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC |
| CAPOX chemotherapyChemotherapy with the CAPOX regimen: Capecitabine tablets are available in strengths of 0.5 g/tablet and 0.15 g/tablet; Oxaliplatin for injection is available in a strength of 0.1 g. The chemotherapy protocol is as follows: After a 7-day rest following radiotherapy, on Day 1 (D1), oxaliplatin is administered intravenously at a dose of 130 mg/m² over 2 hours; from Day 1 to Day 14 of each 3-week cycle, capecitabine is taken orally at a dose of 1000 mg/m² twice daily, with each cycle lasting 3 weeks. | Drug | Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC |
| Targeted therapy with bevacizumabTargeted therapy: On Day 1 (D1) of chemotherapy initiation, bevacizumab will be administered via infusion at a dose of 7.5 mg/kg, with each treatment course lasting 3 weeks, for a total of 6 courses. | Drug | Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC |
| Serplulimab immunotherapyImmunotherapy: On Day 1 (D1) of chemotherapy initiation, administer 300 mg of serplulimab, with each treatment cycle lasting 3 weeks, for a total of 6 cycles. | Drug | Neoadjuvant chemoradiotherapy combined with ICIs and targeted therapy for MSS-type LARC |
Primary outcome
Pathological complete response (pCR) rate
Time frame: After the completion of these cycles, surgical treatment will be scheduled as appropriate (within 1-2 weeks) based on the assessment results. Pathological evaluation of the postoperative specimens will be conducted according to the tumor TRG criteria.
In tumor specimens obtained from modified neoadjuvant chemoradiotherapy combined with immunotherapy followed by TME surgical resection, no cancer cells or local lymph node metastasis of cancer cells (ypT0N0M0) are observed under a microscope.
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 16 Jan 2026.
- 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 Short-course radiotherapy, CAPOX chemotherapy and Targeted therapy with bevacizumab in people with Locally Advanced Rectal Cancer (LARC), run by First Affiliated Hospital of Wenzhou Medical University 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 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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 Yifei Pan, Master's Degree in Medicine (86 13506641535, 13506641535@139.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: After the completion of these cycles, surgical treatment will be scheduled as appropriate (within 1-2 weeks) based on the assessment results. Pathological evaluation of the postoperative specimens will be conducted according to the tumor TRG criteria.). 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 16 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.