Rectal CancerPhase 2NCT07198165
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
A Phase 2 study testing PD-1 inhibitor based immunotherapy in people with Rectal Cancer and Rectal Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Rectal Adenocarcinoma, Rectal Cancer, Radiotherapy
- What is being tested?
- PD-1 inhibitor based immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 31 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
- Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.
- Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.
- Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET/CT.
- Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.
- Age 18 to 75 years.
- ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.
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- Adequate organ function:
- Hematopoietic: Hemoglobin ≥90 g/L, Platelets ≥80 × 10^9/L, Absolute Neutrophil Count ≥1.5 × 10^9/L.
- Hepatic: ALT and AST < 2.5 × ULN. Renal: Serum Creatinine < 1.5 × ULN.
- Provision of signed and dated written informed consent.
Who cannot join
- Patients found to have BRAF mutations or MSI-H status.
- Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.
- History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.
- Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.
- Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.
- Patients with active infections.
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- Poor overall health status, with an ECOG performance status ≥2.
- Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.
- Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.
- Known hypersensitivity to any of the study drugs.
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
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Bo Feng, +86 21 64370045, Fengbo2022@163.com
About this study
Official title: Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.
- Conditions
- Rectal Cancer, Rectal Adenocarcinoma, Rectal Cancer, Radiotherapy, Rectal Cancer Patients, Immunotherapy, Total Neoadjuvant Therapy
- Being tested
- PD-1 inhibitor based immunotherapy
- Keywords
- Rectal cancer, Total Neoadjuvant Therapy, Immunotherapy, Targeted therapy, 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.
PD-1 inhibitor based immunotherapyDrug
Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) .Following completion of total neoadjuvant therapy, the treatment strategy (watch-and-wait or surgical resection) will be selected based on tumor response. The decision regarding adjuvant chemotherapy will be determined according to postoperative pathological findings. |
| Intervention group | Experimental | Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w). Following completion of total neoadjuvant therapy, the treatment strategy (watch-and-wait or surgical resection) will be selected based on tumor response. The decision regarding adjuvant chemotherapy will be determined according to postoperative pathological findings. Receives: Drug: PD-1 inhibitor based immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response rate
Measurement Methods:
Chi-square test, Fisher's exact test, multivariate regression analysis (Cox regression model).
Description:
For pCR and cCR, chi-square test or Fisher's exact test was used to compare differences between the two groups. Multivariate regression analysis (Cox regression model) was employed to assess the relationship between the intervention and the CR rate.
Measured: 2 weeks after the surgery
Secondary outcomes (7)
Disease-Free Survival (DFS)
Measurement Method:
Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.
Methods for Handling Missing Values:
- For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
- For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.
Measured: from enrollment to the end of follow-up at 48 months
Distant Metastasis Rate
Measurement Method:
Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.
Methods for Handling Missing Values:
- For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
- For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.
Measured: from enrollment to the end of follow-up at 48 months
Local Recurrence Rate
Measurement Method:
Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.
Methods for Handling Missing Values:
- For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
- For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.
Measured: from enrollment to the end of follow-up at 48 months
Overall Survival (OS)
Measurement Method:
Kaplan-Meier survival analysis, Log-rank test to compare survival curves between the two groups.
Methods for Handling Missing Values:
- For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
- For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.
Measured: from enrollment to the end of follow-up at 48 months
Pathological Stage
ypT and ypN staging
Measurement Method:
Chi-square test or Fisher's exact test
Measured: 2 weeks after the surgery
Tumor Regression Grade(TRG)
Measurement Method:
Chi-square test or Fisher's exact test
Measured: 2 weeks after the surgery
Sphincter Preservation Rate
Measurement Method:
Logistic regression analysis
Methods for Handling Missing Values:
- For missing data, the Last Observation Carried Forward (LOCF) method or multiple imputation method will be applied.
- For subjects with significant non-compliance or loss to follow-up, sensitivity analysis will be considered to assess the impact on results.
Measured: 2 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start5 Sep 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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 Ruijin 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Feng, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198165
- Sponsor's protocol ID
- TRAINER-2
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07198165
- Acronym / sponsor ID
- TRAINER-2
- Conditions
- Rectal Cancer, Rectal Adenocarcinoma, Rectal Cancer, Radiotherapy, Rectal Cancer Patients, Immunotherapy, Total Neoadjuvant Therapy
- Keywords
- Rectal cancer, Total Neoadjuvant Therapy, Immunotherapy, Targeted therapy, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Sep 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.
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) .Following completion of total neoadjuvant therapy, the treatment strategy (watch-and-wait or surgical resection) will be selected based on tumor response. The decision regarding adjuvant chemotherapy will be determined according to postoperative pathological findings. |
| Intervention group | Experimental | Drug: PD-1 inhibitor based immunotherapyShort-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w). Following completion of total neoadjuvant therapy, the treatment strategy (watch-and-wait or surgical resection) will be selected based on tumor response. The decision regarding adjuvant chemotherapy will be determined according to postoperative pathological findings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.
- Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.
- Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET/CT.
- Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.
- Age 18 to 75 years.
Key exclusion criteria (10 listed)
- Patients found to have BRAF mutations or MSI-H status.
- Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.
- History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.
- Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.
- Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.
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 |
|---|---|---|
| PD-1 inhibitor based immunotherapyShort-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w). | Drug | Intervention group |
Primary outcome
Complete Response rate
Time frame: 2 weeks after the surgery
Measurement Methods: Chi-square test, Fisher's exact test, multivariate regression analysis (Cox regression model). Description: For pCR and cCR, chi-square test or Fisher's exact test was used to compare differences between the two groups. Multivariate regression analysis (Cox regression model) was employed to assess the relationship between the intervention and the CR rate.
7 secondary outcomes
Disease-Free Survival (DFS)
Time frame: from enrollment to the end of follow-up at 48 months
Distant Metastasis Rate
Time frame: from enrollment to the end of follow-up at 48 months
Local Recurrence Rate
Time frame: from enrollment to the end of follow-up at 48 months
Overall Survival (OS)
Time frame: from enrollment to the end of follow-up at 48 months
Pathological Stage
Time frame: 2 weeks after the surgery
Tumor Regression Grade(TRG)
Time frame: 2 weeks after the surgery
Sphincter Preservation Rate
Time frame: 2 weeks after the surgery
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 30 Sep 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 PD-1 inhibitor based immunotherapy in people with Rectal Cancer and Rectal Adenocarcinoma, run by Ruijin Hospital 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 10 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 30 Sep 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 Bo Feng (+86 21 64370045 ext. +86 1351210399, Fengbo2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response rate (time frame: 2 weeks after the surgery). 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 30 Sep 2025.