Locally Advanced Rectal CancerPhase 2NCT06840665
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
A Phase 2 study testing PD-1 antibody, Oxaliplatin and Capecitabine in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. 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?
- PD-1 antibody, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 12 Feb 2027
- 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 18-70 years old, male or female
- Pathologically confirmed rectal adenocarcinoma
- The distance from anal verge ≤ 10 cm
- Clinical stage T3-4 and/or N+
- No evidence of distance metastases
- MSI/MMR status: MSS/pMMR
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- Karnofsky score >=70
- Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
- No chemotherapy or any other anti-tumor therapy prior to enrollment
- No immunotherapy prior to enrollment
- With good compliance during the study
- Signed written informed consent
Who cannot join
- Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
- Pregnancy or breast-feeding women
- Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
- Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
- Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
- Individuals with autoimmune diseases
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- Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
- Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L
- Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
- Individuals allergic to any drug component of the study
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Zhang Zhen, MD PhD, +86 18017312217, zhen_zhang@fudan.edu.cn
About this study
Official title: A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- PD-1 antibody, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Also called Toripalimab
PD-1 antibody (Toripalimab): 240mg d1 q3w
OxaliplatinDrug
Oxaliplatin: 130mg/m2 d1 q3w
CapecitabineDrug
Capecitabine: 1000mg/m2 bid d1-14 q3w
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The patients will receive conventional pelvic radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT. Receives: Drug: PD-1 antibody; Drug: Oxaliplatin; Drug: Capecitabine |
| Group B | Experimental | The patients will receive lymph node-sparing radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT. Receives: Drug: PD-1 antibody; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Rate of pathologic complete response (pCR) after surgery
Measured: 1 month after the surgery
Secondary outcomes (6)
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Measured: From the date of randomization until 3 months after the completion neoadjuvant therapy
Anal function
Anal function will be evaluated using LARS score
Measured: From the date of randomization until 36 months after the surgery
Surgical complication
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measured: The surgical complications were assessed within 3 months after the surgery
3-year local recurrence free survival (LRFS) rate
Rate of 3-year local recurrence free survival
Measured: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months
3-year disease free survival (DFS) rate
Rate of 3-year disease free survival
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
3-year overall survival (OS) rate
Rate of 3-year overall survival
Measured: From the date of randomization until the date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start13 Aug 2024
- Primary completion12 Aug 2026 (estimated)
- Study completion12 Feb 2027 (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.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840665
- Sponsor's protocol ID
- FDRT-2024-293-3847
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06840665
- Acronym / sponsor ID
- FDRT-2024-293-3847
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 12 Aug 2026 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 21 Feb 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.
NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PD-1 antibody, Drug: Oxaliplatin, Drug: CapecitabineThe patients will receive conventional pelvic radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT. |
| Group B | Experimental | Drug: PD-1 antibody, Drug: Oxaliplatin, Drug: CapecitabineThe patients will receive lymph node-sparing radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-70 years old, male or female
- Pathologically confirmed rectal adenocarcinoma
- The distance from anal verge ≤ 10 cm
- Clinical stage T3-4 and/or N+
- No evidence of distance metastases
Key exclusion criteria (10 listed)
- Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
- Pregnancy or breast-feeding women
- Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
- Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
- Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone 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 |
|---|---|---|
| PD-1 antibodyAlso: ToripalimabPD-1 antibody (Toripalimab): 240mg d1 q3w | Drug | Group A, Group B |
| OxaliplatinOxaliplatin: 130mg/m2 d1 q3w | Drug | Group A, Group B |
| CapecitabineCapecitabine: 1000mg/m2 bid d1-14 q3w | Drug | Group A, Group B |
Primary outcome
Pathological complete response (pCR) rate
Time frame: 1 month after the surgery
Rate of pathologic complete response (pCR) after surgery
6 secondary outcomes
Grade 3-4 adverse effects rate
Time frame: From the date of randomization until 3 months after the completion neoadjuvant therapy
Anal function
Time frame: From the date of randomization until 36 months after the surgery
Surgical complication
Time frame: The surgical complications were assessed within 3 months after the surgery
3-year local recurrence free survival (LRFS) rate
Time frame: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months
3-year disease free survival (DFS) rate
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
3-year overall survival (OS) rate
Time frame: From the date of randomization until the date of death from any cause, assessed up to 36 months
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 21 Feb 2025.
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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 antibody, Oxaliplatin and Capecitabine in people with Locally Advanced Rectal Cancer, run by Fudan 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 12 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 21 Feb 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 Zhen Zhang, MD (+86 18017312217, zhen_zhang@fudan.edu.cn), 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: 1 month 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 21 Feb 2025.