Locally AdvancedNCT05877573
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
A study testing Toripalimab, short-term radiotherapy and Oxaliplatin in people with Locally Advanced and High-Risk, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced, High-Risk, Rectal Cancer
- What is being tested?
- Toripalimab, short-term radiotherapy and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old, female and male;
- Pathological confirmed MSS or pMMR rectal adenocarcinoma;
- Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
- Adequate organ function defined at baseline as:
- ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr
- 60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);
- Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;
Who cannot join
- Pathological confirmed rectal squamous cell carcinoma;
- History of other uncured malignancies within 5 years;
- Allergic to any component of chemotherapy or immunotherapy;
- History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.
- With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510000
Yaowei Zhang, MD, 86-20-17819575181, weiyaozhang2@163.com
About this study
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
- Conditions
- Locally Advanced, High-Risk, Rectal Cancer, MSS
- Being tested
- Toripalimab, short-term radiotherapy, Oxaliplatin, Capecitabine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240mg,d1,q3w
short-term radiotherapyRadiation
Also called shor-course radiotherapy
25Gy/5Fx
OxaliplatinDrug
135mg/m2 d1 q3w
CapecitabineDrug
1200mg/m2 d1-14 q3w
| Study group | Role | What they receive |
|---|---|---|
| short-course radiotherapy plus chemotherapy and immunotherapy | Experimental | A total of 53 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy. Receives: Drug: Toripalimab; Radiation: short-term radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathologic complete response rate
Measured: The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Secondary outcomes (5)
3-year ORR
3-year objective response rate
Measured: Assessed up to 3 years
3-year DCR
3-year disease control rate
Measured: Assessed up to 3 years
3-year OS
3-year overall survival rate
Measured: Assessed up to 3 years
AE
adverse event
Measured: Assessed up to 3 years
SAE
Serious Adverse Event
Measured: Assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally AdvancedStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dehua Wu, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877573
- Sponsor's protocol ID
- NFEC-2023-062
- Status last verified
- Jul 2023
- First submitted
- 17 May 2023
- Last updated
- 5 Jul 2023
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
- ClinicalTrials.gov ID
- NCT05877573
- Acronym / sponsor ID
- NFEC-2023-062
- Conditions
- Locally Advanced, High-Risk, Rectal Cancer, MSS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 May 2023 (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 a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| short-course radiotherapy plus chemotherapy and immunotherapy | Experimental | Drug: Toripalimab, Radiation: short-term radiotherapy, Drug: Oxaliplatin, Drug: CapecitabineA total of 53 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old, female and male;
- Pathological confirmed MSS or pMMR rectal adenocarcinoma;
- Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
- Adequate organ function defined at baseline as:
Key exclusion criteria (5 listed)
- Pathological confirmed rectal squamous cell carcinoma;
- History of other uncured malignancies within 5 years;
- Allergic to any component of chemotherapy or immunotherapy;
- History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.
- With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
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 |
|---|---|---|
| ToripalimabToripalimab 240mg,d1,q3w | Drug | short-course radiotherapy plus chemotherapy and immunotherapy |
| short-term radiotherapyAlso: shor-course radiotherapy25Gy/5Fx | Radiation | short-course radiotherapy plus chemotherapy and immunotherapy |
| Oxaliplatin135mg/m2 d1 q3w | Drug | short-course radiotherapy plus chemotherapy and immunotherapy |
| Capecitabine1200mg/m2 d1-14 q3w | Drug | short-course radiotherapy plus chemotherapy and immunotherapy |
Primary outcome
pCR rate
Time frame: The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Pathologic complete response rate
5 secondary outcomes
3-year ORR
Time frame: Assessed up to 3 years
3-year DCR
Time frame: Assessed up to 3 years
3-year OS
Time frame: Assessed up to 3 years
AE
Time frame: Assessed up to 3 years
SAE
Time frame: Assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- 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. This study is not recruiting at the moment.
Dehua Wu, MD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toripalimab, short-term radiotherapy and Oxaliplatin in people with Locally Advanced and High-Risk, run by Nanfang Hospital, Southern Medical 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ding, MD (86-20-13729852980, dingyi197980@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 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 5 Jul 2023.