Locally Advanced Rectal CancerPhase 2TORCHNCT04518280
Short-course Radiotherapy Based TNT Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer
A Phase 2 study testing PD-1 antibody, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Fudan University at 3 sites in China.
Trial summary
TORCH is a prospective, multicentre, randomized phase II trial. 130 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. Group A receives SCRT (25Gy/5Fx) followed by 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
- What is being tested?
- PD-1 antibody, Capecitabine and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesChina
- Study dates
- 1 May 2021to 1 Jan 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological confrmed adenocarcinoma
- Clinical stage T3-4 and/or N+
- The distance from anal verge ≤12 cm
- Without distance metastases
- Age 18-70 years old, female and male
- KPS > =70
- 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 previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc
- 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
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- Uncontrolled infection which needs systemic therapy
- Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents
- Known history of human immunodefciency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
- Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (i.e., HBsAg positive or HBV DNA positive, HCV RNA positive if anti-HCV antibody testing positive)
- Allergic to any component of the therapy
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200032
Zhen Zhang
Shanghai, Shanghai Municipality, 200032
Shanghai East Hospital
Shanghai
About this study
Official title: A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer (TORCH）
TORCH is a prospective, multicentre, randomized phase II trial. 130 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. Group A receives SCRT (25Gy/5Fx) followed by 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives 2 cycles of ToriCAPOX followed by SCRT and 4 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, 3-year DFS rate, etc.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- PD-1 antibody, Capecitabine, Oxaliplatin, Short-course radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Also called Toripalimab
PD-1 antibody (Toripalimab): 240mg d1 q3w
CapecitabineDrug
Also called Xeloda
Capecitabine: 1000mg/m2 bid d1-14 q3w
OxaliplatinDrug
Oxaliplatin: 130mg/m2 d1 q3w
Short-course radiotherapyRadiation
Shor-course radiotherapy: 25Gy/5Fx
| Study group | Role | What they receive |
|---|---|---|
| Group A | 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 antibody; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Short-course radiotherapy |
| Group B | Experimental | The patients will firstly receive 2 cycles of CAPOX and PD-1 antibody, then receive short-course radiotherapy (25Gy/5Fx), followed by 4 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 antibody; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Short-course radiotherapy |
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: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.
Secondary outcomes (6)
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
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 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 surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 5 years from the surgery.
Scores of Quality of Life
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 May 2021
- Primary completion1 Sep 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, M.D, PH.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518280
- Sponsor's protocol ID
- FDRT-2020-236-2156
- Acronym
- TORCH
- Status last verified
- Jan 2025
- First submitted
- 15 Aug 2020
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xia F, Wang Y, Wang H, Shen L, Xiang Z, Zhao Y, Zhang H, Wan J, Zhang H, Wang Y, Wu R, Wang J, Yang W, Zhou M, Zhou S, Chen Y, Zhang Z, Wu X, Xuan Y, Wang R, Sun Y, Tong T, Zhang X, Wang L, Huang D, Sheng W, Yan H, Yang X, Shen Y, Xu Y, Zhao R, Mo M, Cai G, Cai S, Xu Y, Zhang Z. Randomized Phase II Trial of Immunotherapy-Based Total Neoadjuvant Therapy for Proficient Mismatch Repair or Microsatellite Stable Locally Advanced Rectal Cancer (TORCH). J Clin Oncol. 2024 Oct;42(28):3308-3318. doi: 10.1200/JCO.23.02261. Epub 2024 Jul 1.
PubMed 38950321Wang Y, Shen L, Wan J, Zhang H, Wu R, Wang J, Wang Y, Xu Y, Cai S, Zhang Z, Xia F. Short-course radiotherapy combined with CAPOX and Toripalimab for the total neoadjuvant therapy of locally advanced rectal cancer: a randomized, prospective, multicentre, double-arm, phase II trial (TORCH). BMC Cancer. 2022 Mar 15;22(1):274. doi: 10.1186/s12885-022-09348-z.
PubMed 35291966
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer (TORCH）
- ClinicalTrials.gov ID
- NCT04518280
- Acronym / sponsor ID
- TORCH / FDRT-2020-236-2156
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Aug 2020 (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 is a prospective, multicentre, randomized phase II trial. 130 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. Group A receives SCRT (25Gy/5Fx) followed by 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives 2 cycles of ToriCAPOX followed by SCRT and 4 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, 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 |
|---|---|---|
| Group A | Experimental | Drug: PD-1 antibody, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Short-course radiotherapyThe 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. |
| Group B | Experimental | Drug: PD-1 antibody, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Short-course radiotherapyThe patients will firstly receive 2 cycles of CAPOX and PD-1 antibody, then receive short-course radiotherapy (25Gy/5Fx), followed by 4 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 (8 listed)
- Pathological confrmed adenocarcinoma
- Clinical stage T3-4 and/or N+
- The distance from anal verge ≤12 cm
- Without distance metastases
- Age 18-70 years old, female and male
Key exclusion criteria (11 listed)
- Pregnancy or breast-feeding women
- Known history of other malignancies within 5 years
- Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc
- 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
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 antibodyAlso: ToripalimabPD-1 antibody (Toripalimab): 240mg d1 q3w | Drug | Group A, Group B |
| CapecitabineAlso: XelodaCapecitabine: 1000mg/m2 bid d1-14 q3w | Drug | Group A, Group B |
| OxaliplatinOxaliplatin: 130mg/m2 d1 q3w | Drug | Group A, Group B |
| Short-course radiotherapyShor-course radiotherapy: 25Gy/5Fx | Radiation | Group A, Group B |
Primary outcome
Complete response (CR) rate
Time frame: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
6 secondary outcomes
Grade 3-4 adverse effects rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
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 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 surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 5 years from the surgery.
Scores of Quality of Life
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 38950321Xia F, Wang Y, Wang H, Shen L, Xiang Z, Zhao Y, Zhang H, Wan J, Zhang H, Wang Y, Wu R, Wang J, Yang W, Zhou M, Zhou S, Chen Y, Zhang Z, Wu X, Xuan Y, Wang R, Sun Y, Tong T, Zhang X, Wang L, Huang D, Sheng W, Yan H, Yang X, Shen Y, Xu Y, Zhao R, Mo M, Cai G, Cai S, Xu Y, Zhang Z. Randomized Phase II Trial of Immunotherapy-Based Total Neoadjuvant Therapy for Proficient Mismatch Repair or Microsatellite Stable Locally Advanced Rectal Cancer (TORCH). J Clin Oncol. 2024 Oct;42(28):3308-3318. doi: 10.1200/JCO.23.02261. Epub 2024 Jul 1.
- Derived from this study: PubMed 35291966Wang Y, Shen L, Wan J, Zhang H, Wu R, Wang J, Wang Y, Xu Y, Cai S, Zhang Z, Xia F. Short-course radiotherapy combined with CAPOX and Toripalimab for the total neoadjuvant therapy of locally advanced rectal cancer: a randomized, prospective, multicentre, double-arm, phase II trial (TORCH). BMC Cancer. 2022 Mar 15;22(1):274. doi: 10.1186/s12885-022-09348-z.
- TORCH JCO 2024Link provided by the sponsor.
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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.
Zhen Zhang, M.D, PH.D principal investigator
Fudan University
3 sites 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, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Fudan University at 3 sites 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 11 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518280, which also lists 2 linked publications.
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 17 Jan 2025.