Recurrent Rectal CancerPhase 2TRACERNCT06751394
Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer
A Phase 2 study testing PD-1 antibody (Toripalimab), Capecitabine and Oxaliplatin in people with Recurrent Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Rectal Cancer
- What is being tested?
- PD-1 antibody (Toripalimab), Capecitabine and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 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
- Patient is 18-75 years old at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
- No distant metastasis lesions outside the pelvic.
- No prior radiotherapy within 6 months.
- Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.
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- Life expectancy at least 24 weeks.
- 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 pregnancy or lactation.
- Fully informed and willing to provide written informed consent for the trial.
Who cannot join
- Neutrophil < 1.5×10^9/L, PLT < 75×10^9/L.
- TBIL > 1.5 ULN.
- AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN.
- Serious electrolyte abnormalities.
- Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months.
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- Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.
- Congestive cardiac failure ≥ NYHA grade 2.
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml; hepatitis C defined as HCV-RNA higher than lower limit of detection) or hepatitis B and hepatitis C virus co-infection.
- Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.
- Suspected autoimmune disease.
- Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
- Suspected allergic to any drugs used in the trial.
- History of any immune checkpoint inhibitor therapy.
- Clinically detectable second primary malignancy, or history of other malignancies within 5 years.
- 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.
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
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)
The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .
The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
- Conditions
- Recurrent Rectal Cancer
- Being tested
- PD-1 antibody (Toripalimab), Capecitabine, Oxaliplatin, Irinotecan, Radiation
- Keywords
- locally recurrent rectal cancer; PD-1 inhibitor; preoperative 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 antibody (Toripalimab)Drug
PD-1 antibody: (Toripalimab): 240mg q3w
CapecitabineDrug
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
OxaliplatinDrug
130 mg/m² q3w
IrinotecanDrug
200 mg/m² q3w
RadiationRadiation
45-50Gy/25Fx or 30Gy/15Fx
surgeryProcedure or surgery
The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The patients will receive 2 cycles of XELOX or XELIRI and PD-1 antibody, followed by long course radiotherapy (45-50Gy/25f or 30Gy/25f), concurrent with Capecitabine and 1-2 cycles of PD-1 antibody, then receive 2-3 cycles of XELOX or XELIRI and PD-1 antibody. Curative surgery is scheduled after neoadjuvant treatment. Receives: Drug: PD-1 antibody (Toripalimab); Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan; Radiation: Radiation; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Defined as pathological evaluation of resected tumor tissue and regional lymph nodes, with no residual tumor cells, complete disappearance of all tumor lesions, and no appearance of new lesions.
Measured: up to 1 year
Secondary outcomes (6)
R0 resection rate
Complete resection rate, defined as no residual tumor cells at the surgical margin under the microscope or the naked eye.
Measured: up to 1 year
3-year Progression-Free Survival
Defined as the time from the date of start treatment until the date of local recurrence or local recurrence progression or distant metastases or death from any cause or censored at last follow-up within 3 years.
Measured: up to 3 years
Overall Survival
Defined as the time from the date of start treatment until the date of death from any cause or censored at last follow-up.
Measured: up to 3 years
Pathological tumor regression grading
Classify according to the Mandard tumor regression grading system.
Measured: up to 1 year
Operation complications
intraoperative complications
Measured: up to 1 year
Incidence of major surgical complications
From the date of surgery to 3 months after surgery, according to Clavien-Dindo classification score.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751394
- Sponsor's protocol ID
- 2024ZSLYEC-684
- Acronym
- TRACER
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)
- ClinicalTrials.gov ID
- NCT06751394
- Acronym / sponsor ID
- TRACER / 2024ZSLYEC-684
- Conditions
- Recurrent Rectal Cancer
- Keywords
- locally recurrent rectal cancer; PD-1 inhibitor; preoperative chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Dec 2024 (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.
The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .
The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PD-1 antibody (Toripalimab), Drug: Capecitabine, Drug: Oxaliplatin, Drug: Irinotecan, Radiation: Radiation, Procedure: surgeryThe patients will receive 2 cycles of XELOX or XELIRI and PD-1 antibody, followed by long course radiotherapy (45-50Gy/25f or 30Gy/25f), concurrent with Capecitabine and 1-2 cycles of PD-1 antibody, then receive 2-3 cycles of XELOX or XELIRI and PD-1 antibody. Curative surgery is scheduled after neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is 18-75 years old at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
- No distant metastasis lesions outside the pelvic.
- No prior radiotherapy within 6 months.
Key exclusion criteria (18 listed)
- Neutrophil < 1.5×10^9/L, PLT < 75×10^9/L.
- TBIL > 1.5 ULN.
- AST or ALT > 2.5 ULN, or ALT and / or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN.
- Serious electrolyte abnormalities.
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 antibody (Toripalimab)PD-1 antibody: (Toripalimab): 240mg q3w | Drug | Group A |
| CapecitabineCapecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy | Drug | Group A |
| Oxaliplatin130 mg/m² q3w | Drug | Group A |
| Irinotecan200 mg/m² q3w | Drug | Group A |
| Radiation45-50Gy/25Fx or 30Gy/15Fx | Radiation | Group A |
| surgeryThe type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons. | Procedure or surgery | Group A |
Primary outcome
Pathological complete response rate
Time frame: up to 1 year
Defined as pathological evaluation of resected tumor tissue and regional lymph nodes, with no residual tumor cells, complete disappearance of all tumor lesions, and no appearance of new lesions.
6 secondary outcomes
R0 resection rate
Time frame: up to 1 year
3-year Progression-Free Survival
Time frame: up to 3 years
Overall Survival
Time frame: up to 3 years
Pathological tumor regression grading
Time frame: up to 1 year
Operation complications
Time frame: up to 1 year
Incidence of major surgical complications
Time frame: up to 3 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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 (Toripalimab), Capecitabine and Oxaliplatin in people with Recurrent Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 10 inclusion and 18 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: opening soon, as of the sponsor's last update on 27 Dec 2024. 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 Xiaojian Wu (86-020-38455325, wuxjian@mail.sysu.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 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 27 Dec 2024.