Colorectal CancerPhase 2NCT07154316
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
A Phase 2 study testing LCRT, SCRT and CAPOX in people with Colorectal Cancer, run by Fudan University at 5 sites in China.
Trial summary
This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- LCRT, SCRT and CAPOX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2025to 30 Dec 2028
- 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
- Age 18-75 years, regardless of gender.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor located ≤10 cm from the anal verge.
- Baseline stage T3-4 and/or N+ (locally advanced disease).
- No evidence of distant metastasis.
- Microsatellite stability (MSS) or proficient mismatch repair (pMMR).
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- Karnofsky Performance Status (KPS) ≥70.
- No prior chemotherapy or any other anticancer therapy before enrollment.
- No prior immunotherapy.
- Able to comply with study protocol requirements throughout the study period.
- Signed written informed consent obtained prior to study participation.
Who cannot join
- Pregnant or lactating women.
- Individuals with a history of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ.
- Individuals with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the clinical severity (as judged by the investigator) may impair the ability to sign the informed consent form or affect compliance with oral medication.
- Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months.
- Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy.
- Individuals with autoimmune diseases.
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- Individuals with severe, uncontrolled, recurrent infections or other severe, uncontrolled concurrent diseases.
- Baseline blood routine and biochemical parameters not meeting the following criteria: hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets ≥100×10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5×ULN; serum total bilirubin <1.5×ULN; serum creatinine <1×ULN; serum albumin ≥30 g/L.
- Individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency. Individuals with a history of hypersensitivity to any component of the study medications.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang, Henan, 455100
Yanjun Wang, +86-0372-2232178
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Shen Guan, +86-0591-83660063
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Jingbo Chen, +86-0531-89268900
- Recruiting
Yunnan Cancer Hospital
Kunming, 650118
Xinyi Cai, +86-0871-68185656
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Dawei Li, +86-021-64175590, li_dawei@fudan.edu.cn
About this study
Official title: A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer
This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)（Complete Remission） and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.
- Conditions
- Colorectal Cancer
- Being tested
- LCRT, SCRT, CAPOX, PD-1, Celecoxib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCRTRadiation
50Gy/25Fx
SCRTRadiation
25Gy/5Fx
CAPOXDrug
1000mg/m2 bid d1-14
PD-1Drug
300mg d1，q3w
CelecoxibDrug
200mg, bid
| Study group | Role | What they receive |
|---|---|---|
| Long-course chemoradiotherapy group | Experimental | The long-course chemoradiotherapy (LC-CRT) arm refers to a preoperative treatment regimen combining normofractionated radiotherapy with concurrent chemotherapy. Receives: Radiation: LCRT; Drug: CAPOX; Drug: PD-1; Drug: Celecoxib |
| Short-course chemoradiotherapy group | Experimental | The short-course chemoradiotherapy group refers to a preoperative regimen combining hypofractionated radiotherapy with concurrent or sequential chemotherapy . Receives: Radiation: SCRT; Drug: CAPOX; Drug: PD-1; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR (Complete Response)
Complete response (CR) in malignant tumor patients is defined as the complete disappearance of all target lesions, normalization of tumor marker levels, and absence of new lesions for ≥4 weeks after treatment.
Measured: 3 years
Secondary outcomes (6)
sphincter preservation rate
Measured: 3 years
Grade 3 or higher toxicity rate
Measured: 3 years
3yPFS (Progression-Free Survival)
PFS (Progression-Free Survival) in oncology is defined as the time from the initiation of treatment to the occurrence of disease progression or death from any cause , whichever occurs first.
Measured: 3 years
3yLRFS (Local Recurrence-Free Survival)
LRFS (Local Recurrence-Free Survival) is a clinical endpoint in oncology that measures the time from treatment initiation to the occurrence of local recurrence or death from any cause , whichever occurs first, commonly used to assess tumor control efficacy after surgery or radiotherapy.
Measured: 3 years
3yOS (Overall Survival)
Measures the time until death , regardless of cause, reflecting the ultimate therapeutic outcome .
Measured: 3 years
Surgical complications
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 posted4 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Anyang Tumor Hospital, Fujian Cancer Hospital, Shandong First Medical University, Yunnan Cancer Hospital
- Responsible party
- Principal investigator, Li Dawei, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154316
- Sponsor's protocol ID
- SERRAC
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07154316
- Acronym / sponsor ID
- SERRAC
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Anyang Tumor Hospital, Fujian Cancer Hospital, Shandong First Medical University, Yunnan Cancer Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 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 randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)（Complete Remission） and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-course chemoradiotherapy group | Experimental | Radiation: LCRT, Drug: CAPOX, Drug: PD-1, Drug: CelecoxibThe long-course chemoradiotherapy (LC-CRT) arm refers to a preoperative treatment regimen combining normofractionated radiotherapy with concurrent chemotherapy. |
| Short-course chemoradiotherapy group | Experimental | Radiation: SCRT, Drug: CAPOX, Drug: PD-1, Drug: CelecoxibThe short-course chemoradiotherapy group refers to a preoperative regimen combining hypofractionated radiotherapy with concurrent or sequential chemotherapy . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years, regardless of gender.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor located ≤10 cm from the anal verge.
- Baseline stage T3-4 and/or N+ (locally advanced disease).
- No evidence of distant metastasis.
Key exclusion criteria (9 listed)
- Pregnant or lactating women.
- Individuals with a history of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ.
- Individuals with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the clinical severity (as judged by the investigator) may impair the ability to sign the informed consent form or affect compliance with oral medication.
- Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months.
- Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy.
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 |
|---|---|---|
| LCRT50Gy/25Fx | Radiation | Long-course chemoradiotherapy group |
| SCRT25Gy/5Fx | Radiation | Short-course chemoradiotherapy group |
| CAPOX1000mg/m2 bid d1-14 | Drug | Long-course chemoradiotherapy group, Short-course chemoradiotherapy group |
| PD-1300mg d1，q3w | Drug | Long-course chemoradiotherapy group, Short-course chemoradiotherapy group |
| Celecoxib200mg, bid | Drug | Long-course chemoradiotherapy group, Short-course chemoradiotherapy group |
Primary outcome
CR (Complete Response)
Time frame: 3 years
Complete response (CR) in malignant tumor patients is defined as the complete disappearance of all target lesions, normalization of tumor marker levels, and absence of new lesions for ≥4 weeks after treatment.
6 secondary outcomes
sphincter preservation rate
Time frame: 3 years
Grade 3 or higher toxicity rate
Time frame: 3 years
3yPFS (Progression-Free Survival)
Time frame: 3 years
3yLRFS (Local Recurrence-Free Survival)
Time frame: 3 years
3yOS (Overall Survival)
Time frame: 3 years
Surgical complications
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 4 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCRT, SCRT and CAPOX in people with Colorectal Cancer, run by Fudan University at 5 sites 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 11 inclusion and 9 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 4 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 5 sites 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 Dawei Li (+86-021-64175590, li_dawei@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (Complete Response) (time frame: 3 years). 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 4 Sep 2025.