Rectal CancerPhase 2NCT06455124
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
A Phase 2 study testing Radiation, PD-1 antibody and Capecitabine in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Radiation, PD-1 antibody and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 30 Dec 2029
- 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 old, female and male
- pathological confirmed adenocarcinoma
- the distance from anal verge ≤ 7 cm
- pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
- refuse radical surgery
- without pelvic or distance metastases
Show all 11Show fewer
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Who cannot join
- pregnancy or breast-feeding women
- pathological confirmed signet ring cell carcinoma
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- allergic to any component of the therapy
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
Zhen Zhang, MD, PHD, 021-64175590, zhen_zhang@fudan.edu.cn
About this study
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.
Read the detailed description
A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.
Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
They will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.
- Conditions
- Rectal Cancer
- Being tested
- Radiation, PD-1 antibody, Capecitabine, Oxaliplatin
- Keywords
- early rectal cancer, high risk, local excision, radiation, PD-1 inhibitor, chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Shor-course radiotherapy: 25Gy/5Fx
PD-1 antibodyDrug
Also called Toripalimab
PD-1 antibody (Toripalimab): 240mg d1 q3w
CapecitabineDrug
Also called Xeloda
Capecitabine: 1000mg/m2 d1-14 q3w
OxaliplatinDrug
Oxaliplatin: 130mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor. Receives: Radiation: Radiation; Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3y LRFS
Rate of 3 year local recurrence free survival rate
Measured: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Secondary outcomes (3)
3y DFS
Rate of 3 year disease free survival
Measured: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3y OS
Rate of 3 year overall survival
Measured: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Measured: From date of initiation of treatment 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 posted12 Jun 2024
- Study start8 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 60 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
- NCT06455124
- Sponsor's protocol ID
- FDRT-2024-31-3584
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the related article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
- ClinicalTrials.gov ID
- NCT06455124
- Acronym / sponsor ID
- FDRT-2024-31-3584
- Conditions
- Rectal Cancer
- Keywords
- early rectal cancer, high risk, local excision, radiation, PD-1 inhibitor, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 12 Jun 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.
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.
Detailed description
A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.
Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
They will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Radiation: Radiation, Drug: PD-1 antibody, Drug: Capecitabine, Drug: OxaliplatinPatients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor. |
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 old, female and male
- pathological confirmed adenocarcinoma
- the distance from anal verge ≤ 7 cm
- pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
- refuse radical surgery
Key exclusion criteria (8 listed)
- pregnancy or breast-feeding women
- pathological confirmed signet ring cell carcinoma
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
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 |
|---|---|---|
| RadiationShor-course radiotherapy: 25Gy/5Fx | Radiation | Arm1 |
| PD-1 antibodyAlso: ToripalimabPD-1 antibody (Toripalimab): 240mg d1 q3w | Drug | Arm1 |
| CapecitabineAlso: XelodaCapecitabine: 1000mg/m2 d1-14 q3w | Drug | Arm1 |
| OxaliplatinOxaliplatin: 130mg/m2 d1 q3w | Drug | Arm1 |
Primary outcome
3y LRFS
Time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Rate of 3 year local recurrence free survival rate
3 secondary outcomes
3y DFS
Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3y OS
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Grade 3-4 adverse effects rate
Time frame: From date of initiation of treatment 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 13 Jun 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the related article, after deidentification (text, tables, figures, and appendices).
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 Radiation, PD-1 antibody and Capecitabine in people with 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 11 inclusion and 8 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 13 Jun 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 Zhen Zhang (021-64175590, 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?
3y LRFS (time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 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 13 Jun 2024.