Rectal CancerPhase 2NCT07297030
SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer
A Phase 2 study testing SIB-SCRT, CAPOX and Immunotherapy in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- SIB-SCRT, CAPOX and Immunotherapy
- 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
- 37 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 1 May 2029
- 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
- Participants must voluntarily agree to join this study and sign an informed consent form.
- Age at the time of signing the informed consent form must be between 18 and 75 years.
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- High-risk locally advanced pMMR/MSS rectal cancer, categorized according to the AJCC/UICC 8th edition clinical staging and in reference to the inclusion criteria of the RAPIDO study, must meet at least one of the following conditions: cT4 stage, cN2 stage, involvement of the mesorectal fascia (MRF), or presence of laterally enlarged lymph nodes, with M0 status.
- The inferior margin of the tumor must be ≤10 cm from the anal verge.
- No prior anti-cancer treatment for rectal cancer (including local-regional and systemic therapy).
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- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- At least one measurable lesion according to RECIST v1.1 criteria.
- Normal function of major organs without severe abnormalities in hematological, cardiovascular, pulmonary, hepatic, renal, or bone marrow function; laboratory tests must meet the following requirements:
- Hemoglobin (Hb) ≥ 70 g/L; White blood cell count (WBC) ≥ 3.0 × 10^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Renal function (serum creatinine, sCr) level ≤ 1.5 times the upper limit of normal (ULN).
Who cannot join
- Evidence of distant metastasis.
- Recurrent rectal cancer.
- Documented allergy to the investigational drug and/or its excipients.
- Contraindications to radiotherapy and/or chemotherapy.
- Women who are pregnant or breastfeeding.
- A history of other malignancies.
- Patients who have participated in other clinical trials involving investigational drugs within the last 6 months.
- Patients deemed inappropriate for inclusion in this study as determined by the investigator.
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
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Huang Liang MD, PhD, 020-38455369, huangl75@mail.sysu.edu.cn
About this study
Official title: A Prospective Single-Arm Phase II Clinical Study of Neoadjuvant Short-Course Radiotherapy With Simultaneous Integrated Boost Combined With Capecitabine-Oxaliplatin and PD-1 Inhibitor Therapy in High-Risk Locally Advanced Rectal Cancer
The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.
- Conditions
- Rectal Cancer
- Being tested
- SIB-SCRT, CAPOX, Immunotherapy
- Keywords
- SIB, PD-1, neoadjuvant chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-SCRTRadiation
The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
CAPOXDrug
- Oxaliplatin 130 mg/m² intravenously on day 1.
- Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
ImmunotherapyDrug
- Tislelizumab 200 mg intravenously on day 1.
| Study group | Role | What they receive |
|---|---|---|
| SIB-SCRT+CAPOX+PD-1 | Experimental | Patients received neoadjuvant treatment consisting of SIB-SCRT ( PTV-GTV 31Gy/5F/6.2Gy) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later. Receives: Radiation: SIB-SCRT; Drug: CAPOX; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Complete Response (CR) rate
The Complete Response (CR) rate refers to the sum of the pathological Complete Response (pCR) rate, defined as the absence of residual cancer cells in the surgical resection specimen observed microscopically, and the probability of patients achieving clinical Complete Response (cCR) who then undergo a watchful waiting (W\&W) approach. The primary endpoint of my study is the CR rate.
Measured: 3 months
Secondary outcomes (6)
Rate of ≥Grade 3 toxicities
This endpoint measures the incidence of adverse events classified as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE). A Grade 3 toxicity indicates a severe reaction that significantly affects the patient's daily activities and typically requires medical intervention. Monitoring the rate of these serious toxicities will help evaluate the safety profile of the treatment regimen, including neoadjuvant short-course radiotherapy combined with simultaneous integrated boost, immunotherapy, and chemotherapy, in patients with high-risk locally advanced rectal cancer. Assessing these toxicities is critical for understanding the balance between therapeutic efficacy and tolerability in this patient population.
Measured: 3 months
3-Year Disease-Free Survival Rate (3yDFS%)
The 3-Year Disease-Free Survival Rate (3yDFS%) refers to the percentage of patients who do not experience any disease progression within three years after completing the treatment.
Measured: 3 years
3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%)
The 3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%) is defined as the percentage of patients who remain free from locoregional recurrence of cancer for three years after completing the treatment.
Measured: 3 years
3-Year Overall Survival Rate (3yOS%)
This endpoint refers to the percentage of patients who are still alive three years after receiving the treatment, regardless of disease status.
Measured: 3 years
Surgical Complications
This endpoint assesses the occurrence of adverse events related to the surgical procedure performed on patients with high-risk locally advanced rectal cancer. Surgical complications may include infections, bleeding, anastomotic leaks, and any other significant morbidity that may influence the patient's postoperative recovery.
Measured: 6 months
Quality of Life (QoL)
This endpoint evaluates the overall well-being of patients following treatment, focusing on their physical, emotional, and social health. Quality of Life assessments will be performed using validated questionnaires, such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale comprises multiple dimensions, including physical functioning, emotional functioning, and social functioning, with scores ranging from 0 to 100, where higher scores indicate better quality of life.
The assessments will provide insights into patients' functional status and any changes in health-related quality of life resulting from the treatment regimen. Understanding QoL outcomes is essential for assessing the patient-centered effectiveness of the therapeutic approach and ensuring that treatment strategies not only target disease control but also support the overall well-being of patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297030
- Sponsor's protocol ID
- GIHSYSU-38
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Phase II Clinical Study of Neoadjuvant Short-Course Radiotherapy With Simultaneous Integrated Boost Combined With Capecitabine-Oxaliplatin and PD-1 Inhibitor Therapy in High-Risk Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07297030
- Acronym / sponsor ID
- GIHSYSU-38
- Conditions
- Rectal Cancer
- Keywords
- SIB, PD-1, neoadjuvant chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 22 Dec 2025 (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 biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIB-SCRT+CAPOX+PD-1 | Experimental | Radiation: SIB-SCRT, Drug: CAPOX, Drug: ImmunotherapyPatients received neoadjuvant treatment consisting of SIB-SCRT ( PTV-GTV 31Gy/5F/6.2Gy) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must voluntarily agree to join this study and sign an informed consent form.
- Age at the time of signing the informed consent form must be between 18 and 75 years.
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- High-risk locally advanced pMMR/MSS rectal cancer, categorized according to the AJCC/UICC 8th edition clinical staging and in reference to the inclusion criteria of the RAPIDO study, must meet at least one of the following conditions: cT4 stage, cN2 stage, involvement of the mesorectal fascia (MRF), or presence of laterally enlarged lymph nodes, with M0 status.
- The inferior margin of the tumor must be ≤10 cm from the anal verge.
Key exclusion criteria (8 listed)
- Evidence of distant metastasis.
- Recurrent rectal cancer.
- Documented allergy to the investigational drug and/or its excipients.
- Contraindications to radiotherapy and/or chemotherapy.
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| SIB-SCRTThe pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes. | Radiation | SIB-SCRT+CAPOX+PD-1 |
| CAPOX* Oxaliplatin 130 mg/m² intravenously on day 1. * Capecitabine 1,000 mg/m² orally twice daily on days 1-14. | Drug | SIB-SCRT+CAPOX+PD-1 |
| Immunotherapy- Tislelizumab 200 mg intravenously on day 1. | Drug | SIB-SCRT+CAPOX+PD-1 |
Primary outcome
The Complete Response (CR) rate
Time frame: 3 months
The Complete Response (CR) rate refers to the sum of the pathological Complete Response (pCR) rate, defined as the absence of residual cancer cells in the surgical resection specimen observed microscopically, and the probability of patients achieving clinical Complete Response (cCR) who then undergo a watchful waiting (W\&W) approach. The primary endpoint of my study is the CR rate.
6 secondary outcomes
Rate of ≥Grade 3 toxicities
Time frame: 3 months
3-Year Disease-Free Survival Rate (3yDFS%)
Time frame: 3 years
3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%)
Time frame: 3 years
3-Year Overall Survival Rate (3yOS%)
Time frame: 3 years
Surgical Complications
Time frame: 6 months
Quality of Life (QoL)
Time frame: 3 years
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 22 Dec 2025.
- 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 SIB-SCRT, CAPOX and Immunotherapy in people with Rectal Cancer, run by Sun Yat-sen 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 10 inclusion and 8 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 22 Dec 2025. 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 Liang Huang, MD. and Phd. (020-38455369, huangl75@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Complete Response (CR) rate (time frame: 3 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 22 Dec 2025.