Locally Recurrent Rectal CancerPhase 2NCT06928584
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
A Phase 2 study testing Conventional Radiotherapy, Capecitabine and 5-fluorouracil in people with Locally Recurrent Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . 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?
- Conventional Radiotherapy, Capecitabine and 5-fluorouracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 10 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. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. Without synchronous distant metastases. No prior radiotherapy within 6 month. No prior first-line chemotherapy. Has an investigator determined life expectancy of at least 24 weeks. Demonstrate adequate organ function. Non pregnant or lactating patients. Fully informed and willing to provide written informed consent for the trial.
Who cannot join
- Neutrophil< 1.5×109/L, PLT< 100×109/L (PLT< 80×109/L in patients with livermetastasis), or Hb< 90 g/L.
- 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< 50 mL/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-h urine protein ≥1.0 g/24 h. Uncontrolled hypertension: SBP >140 mmHg or DBP > 90 mmHg. A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.
- A history of heart disease within 6 months. Uncontrolled malignant pleural effusion, ascites, or pericardial effusion. History of checkpoint inhibitor therapy. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years.
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- A history of liver disease including, but not limited to, HBV infection or HBV DNA positive (≥1×104/mL), HCV infection or HCV DNA positive (≥1×103/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 3 cm or the total volume is greater than 30 cc. Clinical or radiological evidence of spinal cord compression, or tumors 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: Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)
TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . Patients will be randomized to receive either hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy (experimental arm), or conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and chemotherapy +/- target therapy (control arm). Patiens will be restaged and followed by multidisciplinary team (MDT) for decision: radical surgery, sustained systerm+/- local treatment of non resection.
The primary endpoint was progression-free survival. Secondary endpoints were objective response rate (ORR), complete response rate, R0 resection rate, duration of response (DOR), overall survival (OS), and safety and tolerability of the treatment.
- Conditions
- Locally Recurrent Rectal Cancer
- Being tested
- Conventional Radiotherapy, Capecitabine, 5-fluorouracil, folinic acid, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RadiotherapyRadiation
50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)
CapecitabineDrug
1000mg/m2 d1-14 q3w
5-fluorouracilDrug
400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
folinic acidDrug
400 mg/m2 q2w
OxaliplatinDrug
130 mg/m² q3w or 85 mg/m² q2w
IrinotecanDrug
180 mg/m² q2w and 200 mg/m² q3w
CetuximabDrug
500 mg/m² q2w
BevacizumabDrug
5 mg/kg q2w or 7.5mg/kg q3w
Hypofractionated radiotherapyRadiation
25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)
PD-1 antibodyDrug
Also called Sintilimab
200mg IV q3w
| Study group | Role | What they receive |
|---|---|---|
| Conventional radiotherapy arm | Active comparator | Conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and investigator's choice of first-line chemotherapy +/- target therapy. Receives: Radiation: Conventional Radiotherapy; Drug: Capecitabine; Drug: 5-fluorouracil; Drug: folinic acid; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Cetuximab; Drug: Bevacizumab |
| Hypofractionated radiotherapy plus Immunotherapy arm | Experimental | Hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy. Receives: Drug: Capecitabine; Drug: 5-fluorouracil; Drug: folinic acid; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Cetuximab; Drug: Bevacizumab; Radiation: Hypofractionated radiotherapy; Drug: PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
time from the date of start treatment until disease progression or censored at last follow-up or death.
Measured: up to 3 years
Secondary outcomes (6)
Objective response rate (ORR)
the proportion of patients with the best response of confirmed complete or partial response according to RECIST 1.1, as assessed by the investigator.
Measured: up to 1 year
Complete response rate
the proportion of patients with the best response of confirmed complete response according to RECIST 1.1, as assessed by the investigator.
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 years
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 years
Safety and tolerability
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 posted15 Apr 2025
- Study start10 Mar 2025
- Primary completion10 Mar 2030 (estimated)
- Study completion10 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 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, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928584
- Sponsor's protocol ID
- FDRT-2024-416-3970
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)
- ClinicalTrials.gov ID
- NCT06928584
- Acronym / sponsor ID
- FDRT-2024-416-3970
- Conditions
- Locally Recurrent Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Mar 2030 (estimated)
- Study completion
- 10 Mar 2030 (estimated)
- First posted
- 15 Apr 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.
TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . Patients will be randomized to receive either hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy (experimental arm), or conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and chemotherapy +/- target therapy (control arm). Patiens will be restaged and followed by multidisciplinary team (MDT) for decision: radical surgery, sustained systerm+/- local treatment of non resection.
The primary endpoint was progression-free survival. Secondary endpoints were objective response rate (ORR), complete response rate, R0 resection rate, duration of response (DOR), overall survival (OS), and safety and tolerability of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional radiotherapy arm | Active comparator | Radiation: Conventional Radiotherapy, Drug: Capecitabine, Drug: 5-fluorouracil, Drug: folinic acid, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Cetuximab, Drug: BevacizumabConventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and investigator's choice of first-line chemotherapy +/- target therapy. |
| Hypofractionated radiotherapy plus Immunotherapy arm | Experimental | Drug: Capecitabine, Drug: 5-fluorouracil, Drug: folinic acid, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Cetuximab, Drug: Bevacizumab, Radiation: Hypofractionated radiotherapy, Drug: PD-1 antibodyHypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is 18-75 years. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. Without synchronous distant metastases. No prior radiotherapy within 6 month. No prior first-line chemotherapy. Has an investigator determined life expectancy of at least 24 weeks. Demonstrate adequate organ function. Non pregnant or lactating patients. Fully informed and willing to provide written informed consent for the trial.
Key exclusion criteria (10 listed)
- Neutrophil< 1.5×109/L, PLT< 100×109/L (PLT< 80×109/L in patients with livermetastasis), or Hb< 90 g/L.
- 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< 50 mL/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-h urine protein ≥1.0 g/24 h. Uncontrolled hypertension: SBP >140 mmHg or DBP > 90 mmHg. A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.
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 |
|---|---|---|
| Conventional Radiotherapy50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation) | Radiation | Conventional radiotherapy arm |
| Capecitabine1000mg/m2 d1-14 q3w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| 5-fluorouracil400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr) | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| folinic acid400 mg/m2 q2w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| Oxaliplatin130 mg/m² q3w or 85 mg/m² q2w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| Irinotecan180 mg/m² q2w and 200 mg/m² q3w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| Cetuximab500 mg/m² q2w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| Bevacizumab5 mg/kg q2w or 7.5mg/kg q3w | Drug | Conventional radiotherapy arm, Hypofractionated radiotherapy plus Immunotherapy arm |
| Hypofractionated radiotherapy25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation) | Radiation | Hypofractionated radiotherapy plus Immunotherapy arm |
| PD-1 antibodyAlso: Sintilimab200mg IV q3w | Drug | Hypofractionated radiotherapy plus Immunotherapy arm |
Primary outcome
Progression-Free Survival
Time frame: up to 3 years
time from the date of start treatment until disease progression or censored at last follow-up or death.
6 secondary outcomes
Objective response rate (ORR)
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 years
Overall Survival
Time frame: up to 3 years
Safety and tolerability
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 15 Apr 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, 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 Conventional Radiotherapy, Capecitabine and 5-fluorouracil 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 1 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 15 Apr 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 (86-18801735029, 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?
Progression-Free Survival (time frame: up to 3 years). 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 15 Apr 2025.