Locally Advanced Colon CancerPhase 2TORCH-CNCT05732493
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
A Phase 2 study testing Serplulimab, short-term radiotherapy and Oxaliplatin in people with Locally Advanced Colon Cancer, run by Fudan University.
Trial summary
The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Colon Cancer
- What is being tested?
- Serplulimab, short-term radiotherapy and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed adenocarcinoma
- clinical stage T4 and/or bulky nodes
- the distance from anal verge more than 15 cm
- without distance metastases
- age >=18 years old, female and male
- KPS >=70
Show all 9Show fewer
- without previous anti-cancer therapy or immunotherapy
- with good compliance
- signed the inform consent
Who cannot join
- pregnancy or breast-feeding women
- 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
- allergic to any component of the therapy
About this study
Official title: Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)
The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.
Read the detailed description
This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.
- Conditions
- Locally Advanced Colon Cancer
- Being tested
- Serplulimab, short-term radiotherapy, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab 300mg, d1, q3w
short-term radiotherapyRadiation
Also called Shor-course radiotherapy: 25Gy/5Fx
radiation: 25Gy/5Fx
OxaliplatinDrug
130mg/m2 d1 q3w
CapecitabineDrug
Also called Xeloda
1000mg/m2 d1-14 q3w
| Study group | Role | What they receive |
|---|---|---|
| short-course radiotherapy and immunotherapy | Experimental | A total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery. Receives: Drug: Serplulimab; Radiation: short-term radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine |
| chemotherapy | Active comparator | A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
Measured: The pCR rate will be evaluated after surgery, an average of 4 weeks
Secondary outcomes (6)
R0 resection rate
R0 resection refers to the complete removal of the tumor in the operation with microscopically negative margins
Measured: The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3 year overall survival rate
Rate of 3 years overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 3 years
3 year disease free survival rate
Rate of 3 years 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 3 years.
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related severe adverse events
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
3 year local recurrence free survival rate
Rate of 3 years local recurrence free survival
Measured: From date of randomization until the date of first documented local-regional failure, assessed up to 3 years
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Colon 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
- 120 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
- NCT05732493
- Sponsor's protocol ID
- NeoCRT-COLON
- Acronym
- TORCH-C
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Li Y, Xia F, Sun Y, Shen L, Wan J, Chen Y, Wang Y, Zhou M, Wu R, Zhou S, Wang Y, Liu F, Cai S, Zhang Z. Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C). BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442.
PubMed 38309748
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)
- ClinicalTrials.gov ID
- NCT05732493
- Acronym / sponsor ID
- TORCH-C / NeoCRT-COLON
- Conditions
- Locally Advanced Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2023 (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 evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.
Detailed description
This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-course radiotherapy and immunotherapy | Experimental | Drug: Serplulimab, Radiation: short-term radiotherapy, Drug: Oxaliplatin, Drug: CapecitabineA total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery. |
| chemotherapy | Active comparator | Drug: Oxaliplatin, Drug: CapecitabineA total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pathological confirmed adenocarcinoma
- clinical stage T4 and/or bulky nodes
- the distance from anal verge more than 15 cm
- without distance metastases
- age >=18 years old, female and male
Key exclusion criteria (6 listed)
- pregnancy or breast-feeding women
- 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
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 |
|---|---|---|
| SerplulimabSerplulimab 300mg, d1, q3w | Drug | short-course radiotherapy and immunotherapy |
| short-term radiotherapyAlso: Shor-course radiotherapy: 25Gy/5Fxradiation: 25Gy/5Fx | Radiation | short-course radiotherapy and immunotherapy |
| Oxaliplatin130mg/m2 d1 q3w | Drug | chemotherapy, short-course radiotherapy and immunotherapy |
| CapecitabineAlso: Xeloda1000mg/m2 d1-14 q3w | Drug | chemotherapy, short-course radiotherapy and immunotherapy |
Primary outcome
pCR
Time frame: The pCR rate will be evaluated after surgery, an average of 4 weeks
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
6 secondary outcomes
R0 resection rate
Time frame: The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3 year overall survival rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 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 3 years.
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 local recurrence free survival rate
Time frame: From date of randomization until the date of first documented local-regional failure, assessed up to 3 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 38309748Zhang H, Li Y, Xia F, Sun Y, Shen L, Wan J, Chen Y, Wang Y, Zhou M, Wu R, Zhou S, Wang Y, Liu F, Cai S, Zhang Z. Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C). BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, short-term radiotherapy and Oxaliplatin in people with Locally Advanced Colon Cancer, run by Fudan University.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pCR (time frame: The pCR rate will be evaluated after surgery, an average of 4 weeks). 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 NCT05732493, which also lists 1 linked publication.
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 Feb 2023.