Locally Advanced Rectal CancerPhase 2TORCH-iTNTNCT06281405
CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
A Phase 2 study testing PD-1 inhibitor, Capecitabine and Short-course radiotherapy in people with Locally Advanced Rectal Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.
Trial summary
TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Rectal Cancer, Neoadjuvant Therapy
- What is being tested?
- PD-1 inhibitor, Capecitabine and Short-course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, female and male;
- Pathological confirmed adenocarcinoma;
- The distance from anal verge ≤ 10 cm;
- MSI/MMR status: MSS/pMMR;
- Clinical stage T3-4 and/or N+, without distance metastases;
- At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;
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- KPS ≥ 70;
- No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
- Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
- With good compliance and signed the consent form.
Who cannot join
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
- Uncontrolled infection which needs systemic therapy;
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- Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
- 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, 18801735029, zhen_zhang@fudan.edu.cn
About this study
Official title: A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)
TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.
- Being tested
- PD-1 inhibitor, Capecitabine, Short-course radiotherapy, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
Also called Toripalimab
PD-1 inhibitor (Toripalimab): 240mg d1 q3w
CapecitabineDrug
Capecitabine: 1000mg/m2 bid d1-14 q3w
Short-course radiotherapyRadiation
Short-course radiotherapy: 25Gy/5Fx
OxaliplatinDrug
Oxaliplatin 130mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| Immunochemotherapy group | Experimental | The patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR. Receives: Drug: PD-1 inhibitor; Drug: Capecitabine; Drug: Oxaliplatin |
| Radiation plus immunochemotherapy group | Experimental | The patients will receive short-course radiotherapy (25Gy/5Fx), followed by 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR. Receives: Drug: PD-1 inhibitor; Drug: Capecitabine; Radiation: Short-course radiotherapy; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
Measured: 1 month after the surgery or the decision of W&W
Secondary outcomes (7)
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Measured: From date of randomization until 3 months after the completion neoadjuvant therapy
3 year organ or anal preservation rate
3 year organ or anal preservation rate
Measured: From date of randomization until the resection of rectum or anus, assessed up to 36 months.
3 year disease free survival rate
Rate of 3 year disease free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year local recurrence free survival rate
Rate of 3 year local recurrence free survival
Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate
Rate of 3 year distant metastasis free survival
Measured: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.
3 year overall survival rate
Rate of 3 year overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months.
Rate of surgical complications
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measured: The surgical complications were assessed within 3 months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Mar 2024
- Primary completion30 Jun 2026 (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 Locally Advanced 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
- 192 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, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281405
- Sponsor's protocol ID
- FDRT-2023-290-3409
- Acronym
- TORCH-iTNT
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)
- ClinicalTrials.gov ID
- NCT06281405
- Acronym / sponsor ID
- TORCH-iTNT / FDRT-2023-290-3409
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Feb 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.
TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunochemotherapy group | Experimental | Drug: PD-1 inhibitor, Drug: Capecitabine, Drug: OxaliplatinThe patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR. |
| Radiation plus immunochemotherapy group | Experimental | Drug: PD-1 inhibitor, Drug: Capecitabine, Radiation: Short-course radiotherapy, Drug: OxaliplatinThe patients will receive short-course radiotherapy (25Gy/5Fx), followed by 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years old, female and male;
- Pathological confirmed adenocarcinoma;
- The distance from anal verge ≤ 10 cm;
- MSI/MMR status: MSS/pMMR;
- Clinical stage T3-4 and/or N+, without distance metastases;
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
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 inhibitorAlso: ToripalimabPD-1 inhibitor (Toripalimab): 240mg d1 q3w | Drug | Immunochemotherapy group, Radiation plus immunochemotherapy group |
| CapecitabineCapecitabine: 1000mg/m2 bid d1-14 q3w | Drug | Immunochemotherapy group, Radiation plus immunochemotherapy group |
| Short-course radiotherapyShort-course radiotherapy: 25Gy/5Fx | Radiation | Radiation plus immunochemotherapy group |
| OxaliplatinOxaliplatin 130mg/m2 d1 q3w | Drug | Immunochemotherapy group, Radiation plus immunochemotherapy group |
Primary outcome
Complete response (CR) rate
Time frame: 1 month after the surgery or the decision of W&W
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
7 secondary outcomes
Grade 3-4 adverse effects rate
Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy
3 year organ or anal preservation rate
Time frame: From date of randomization until the resection of rectum or anus, assessed up to 36 months.
3 year disease free survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year local recurrence free survival rate
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate
Time frame: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.
3 year overall survival rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.
Rate of surgical complications
Time frame: The surgical complications were assessed within 3 months after the surgery.
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 3 Apr 2026.
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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 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 PD-1 inhibitor, Capecitabine and Short-course radiotherapy in people with Locally Advanced Rectal Cancer and Neoadjuvant Therapy, 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 10 inclusion and 9 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 3 Apr 2026. 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 (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?
Complete response (CR) rate (time frame: 1 month after the surgery or the decision of W&W). 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 3 Apr 2026.