Locally Recurrent Rectal CancerPhase 2NCT07183865
Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)
A Phase 2 study testing radiotherapy, Irinotecan Hydrochloride Liposome and 5-FU in people with Locally Recurrent Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Recurrent Rectal Cancer
- What is being tested?
- radiotherapy, Irinotecan Hydrochloride Liposome and 5-FU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2025to 9 Mar 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
- Patient is 18-75 years old at the time of signing the informed consent form. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. According to RECIST 1.1, there is at least one measurable pelvic lesion.
- Distant metastasis lesions are no more than 5 and metastatic organ are no more than 3.
- No prior radiotherapy within 6 month. Failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression.
- Has an investigator determined life expectancy of at least 24 weeks. Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
- Non pregnant or lactating patients. Effective contraceptive methods should be used during the study and within 6 months of the last administration.
- Fully informed and willing to provide written informed consent for the trial.
Who cannot join
- Previous immunotherapy or Irinotecan Hydrochloride Liposome treatment. Neutrophil < 1.5×10^9/L, PLT < 100×10^9/L (PLT < 80×10^9/L in patients with liver metastasis), or Hb < 90g/L; blood transfusion within 2 weeks before enrollment is not allowed to meet the enrollment criteria.
- TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN, or creatinine clearance < 50ml / min (calculated according to Cockcroft Gault formula).
- APTT > 1.5 ULN, PT > 1.5 ULN (subject to the normal value of the clinical trial research center).
- Serious electrolyte abnormalities. Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h. Uncontrolled hypertension: SBP >140mmHg or DBP > 90mmHg. The presence of gastrointestinal diseases such as gastric or duodenal active ulcers, ulcerative colitis or unresected tumours with active bleeding; or other conditions likely to cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation or gastrointestinal fistula after surgical treatment.
- A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.
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- A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF<50%).
- Uncontrolled malignant pleural effusion, ascites, or pericardial effusion. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).
- A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10^4/ml), HCV infection or HCV DNA positive(≥1×10^3/ml) and liver cirrhosis.
- Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication; Or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
- The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
- Serious mental abnormalities. The diameter of brain metastasis is greater than 3cm or the total volume is greater than 30cc.
- Clinical or radiological evidence of spinal cord compression, or tumours within 3 mm of the spinal cord on MRI.
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, 200032
Zhen Zhang, M.D, PH.D, 19521280960, zhen_zhang@fudan.edu.cn
About this study
Official title: Hypofractionated Radiotherapy Combined With Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, PD-1 Antibody and Target Therapy in Locally Recurrent Rectal Cancer(NOVELTY-R)
This is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression. Patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation for pelvic recurrence, 25-50Gy/5Fx irradiation for all metastasis sites, and 8 cycles of NALIRIF + anti-PD1 + target therapy, followed by multidisciplinary team (MDT) for decision: radical surgery, sustained system +/- local treatment of non resection.
The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, complete response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.
- Conditions
- Locally Recurrent Rectal Cancer
- Being tested
- radiotherapy, Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, SG001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
25-40Gy/5Fx or 15-30Gy/5Fx (previous pelvic radiation) for pelvic recurrence. 25-50GY/5Fx for all metastasis tumors. Dose Constraints are based on SABR-COMET 10 trial.
Irinotecan Hydrochloride LiposomeDrug
70mg/m2 (UGT1A1*28 6/6) or 55mg/m2 (UGT1A1*28 6/7), IV, q2w
5-FUDrug
400 mg/m^2 bolus over 2 hours followed by 2400 mg/m^2 continuous infusion over 48 hours d1, q2w
LeucovorinDrug
400mg/m2, IV, q2w
SG001Drug
240mg, IV, q2w
C225Drug
500 mg/m2, IV, q2w
BevacizumabDrug
5mg/kg, IV, q2w
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Radiotherapy:
The enrolled patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence.All metastasis sites will receive 25-50Gy/5Fx irradiation before or between system therapy cycles. Dose Constraints are based on SABR-COMET 10 trial.
System therapy:
Patients will receive Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), PD-1 antibody, target therapy based on the KRAS/NRAS/BRAF mutation station. Receives: Radiation: radiotherapy; Drug: Irinotecan Hydrochloride Liposome; Drug: 5-FU; Drug: Leucovorin; Drug: SG001; Drug: C225; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local objective response rate
the proportion of patients with the best pelvic response of confirmed complete or partial response according to RECIST 1.1, as assessed by the investigator.
Measured: up to 1 year
Secondary outcomes (7)
Extrapelvic objective response rate
proportion of patients with confirmed extrapelvic complete or partial response per RECIST 1.1.
Measured: up to 1 year
Complete response rate
proportion of patients with confirmed complete response per RECIST 1.1.
Measured: up to 1 year
R0 resection rate
the proportion of patients who achieve R0 resection of pelvic recurrent tumour after therapy.
Measured: up to 1 year
Duration of response (DOR)
time from the first documented pelvic objective response to pelvic or extrapelvic disease progression in patients with confirmed response.
Measured: up to 3 year
Progression-Free Survival(PFS)
time from the date of start treatment until disease progression or censored at last follow-up or death.
Measured: up to 3 year
Overall Survival
from the date of start treatment until the date of death from any cause or censored at last follow-up.
Measured: up to 3 year
Safety and tolerability of the treatment
proportion of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start9 Mar 2025
- Primary completion9 Mar 2030 (estimated)
- Study completion9 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183865
- Sponsor's protocol ID
- FDRT-2024-383-3937
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2025
- Last updated
- 19 Sep 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy Combined With Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, PD-1 Antibody and Target Therapy in Locally Recurrent Rectal Cancer(NOVELTY-R)
- ClinicalTrials.gov ID
- NCT07183865
- Acronym / sponsor ID
- FDRT-2024-383-3937
- Conditions
- Locally Recurrent Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 9 Mar 2030 (estimated)
- Study completion
- 9 Mar 2030 (estimated)
- First posted
- 19 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 is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression. Patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation for pelvic recurrence, 25-50Gy/5Fx irradiation for all metastasis sites, and 8 cycles of NALIRIF + anti-PD1 + target therapy, followed by multidisciplinary team (MDT) for decision: radical surgery, sustained system +/- local treatment of non resection.
The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, complete response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: radiotherapy, Drug: Irinotecan Hydrochloride Liposome, Drug: 5-FU, Drug: Leucovorin, Drug: SG001, Drug: C225, Drug: BevacizumabRadiotherapy: The enrolled patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence.All metastasis sites will receive 25-50Gy/5Fx irradiation before or between system therapy cycles. Dose Constraints are based on SABR-COMET 10 trial. System therapy: Patients will receive Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), PD-1 antibody, target therapy based on the KRAS/NRAS/BRAF mutation station. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is 18-75 years old at the time of signing the informed consent form. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. According to RECIST 1.1, there is at least one measurable pelvic lesion.
- Distant metastasis lesions are no more than 5 and metastatic organ are no more than 3.
- No prior radiotherapy within 6 month. Failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression.
- Has an investigator determined life expectancy of at least 24 weeks. Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
- Non pregnant or lactating patients. Effective contraceptive methods should be used during the study and within 6 months of the last administration.
Key exclusion criteria (13 listed)
- Previous immunotherapy or Irinotecan Hydrochloride Liposome treatment. Neutrophil < 1.5×10^9/L, PLT < 100×10^9/L (PLT < 80×10^9/L in patients with liver metastasis), or Hb < 90g/L; blood transfusion within 2 weeks before enrollment is not allowed to meet the enrollment criteria.
- TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN, or creatinine clearance < 50ml / min (calculated according to Cockcroft Gault formula).
- APTT > 1.5 ULN, PT > 1.5 ULN (subject to the normal value of the clinical trial research center).
- Serious electrolyte abnormalities. Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h. Uncontrolled hypertension: SBP >140mmHg or DBP > 90mmHg. The presence of gastrointestinal diseases such as gastric or duodenal active ulcers, ulcerative colitis or unresected tumours with active bleeding; or other conditions likely to cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation or gastrointestinal fistula after surgical treatment.
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 |
|---|---|---|
| radiotherapy25-40Gy/5Fx or 15-30Gy/5Fx (previous pelvic radiation) for pelvic recurrence. 25-50GY/5Fx for all metastasis tumors. Dose Constraints are based on SABR-COMET 10 trial. | Radiation | Treatment Arm |
| Irinotecan Hydrochloride Liposome70mg/m2 (UGT1A1*28 6/6) or 55mg/m2 (UGT1A1*28 6/7), IV, q2w | Drug | Treatment Arm |
| 5-FU400 mg/m^2 bolus over 2 hours followed by 2400 mg/m^2 continuous infusion over 48 hours d1, q2w | Drug | Treatment Arm |
| Leucovorin400mg/m2, IV, q2w | Drug | Treatment Arm |
| SG001240mg, IV, q2w | Drug | Treatment Arm |
| C225500 mg/m2, IV, q2w | Drug | Treatment Arm |
| Bevacizumab5mg/kg, IV, q2w | Drug | Treatment Arm |
Primary outcome
Local objective response rate
Time frame: up to 1 year
the proportion of patients with the best pelvic response of confirmed complete or partial response according to RECIST 1.1, as assessed by the investigator.
7 secondary outcomes
Extrapelvic objective response rate
Time frame: up to 1 year
Complete response rate
Time frame: up to 1 year
R0 resection rate
Time frame: up to 1 year
Duration of response (DOR)
Time frame: up to 3 year
Progression-Free Survival(PFS)
Time frame: up to 3 year
Overall Survival
Time frame: up to 3 year
Safety and tolerability of the treatment
Time frame: up to 1 year
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 19 Sep 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.
Zhen Zhang, MD, PhD principal investigator
Fudan University
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 radiotherapy, Irinotecan Hydrochloride Liposome and 5-FU in people with Locally Recurrent 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 6 inclusion and 13 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 19 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 Zhen Zhang, MD, PhD (18801735029, 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?
Local objective response rate (time frame: up to 1 year). 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 19 Sep 2025.