Locally Advanced Colorectal CancerPhase 2NCT07503639
Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
A Phase 2 study testing SHR-1701, SHR-8068 and Short-course radiotherapy in people with Locally Advanced Colorectal Cancer, run by Fudan University.
Trial summary
This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- SHR-1701, SHR-8068 and Short-course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 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
- Age 18-75 years old, female and male;
- Pathological confirmed adenocarcinoma;
- Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;
- Treatment-naïve and no distance metastases;
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes
This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- SHR-1701, SHR-8068, Short-course radiotherapy, XELOX (Capecitabine and Oxaliplatin), PD-L1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
1800mg d1 q3w
SHR-8068Drug
280mg，C1D1
Short-course radiotherapyRadiation
25Gy/5Fx
XELOX (Capecitabine and Oxaliplatin)Drug
Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w
PD-L1 antibodyDrug
1200mg d1 q3w
cetuximab βDrug
250mg/m2 d1, 500mg/m2 d8 q3w
HRS-7058Drug
200mg bid
HRS-4642Drug
500mg d1, 1200mg d8 q3w
| Study group | Role | What they receive |
|---|---|---|
| MSI-H/dMMR | Experimental | Not described Receives: Drug: SHR-1701; Drug: SHR-8068 |
| MSS-KRAS G12C-Adebrelimab | Experimental | Not described Receives: Radiation: Short-course radiotherapy; Drug: XELOX (Capecitabine and Oxaliplatin); Drug: PD-L1 antibody; Drug: HRS-7058 |
| MSS-KRAS G12C-cetuximab β | Experimental | Not described Receives: Radiation: Short-course radiotherapy; Drug: XELOX (Capecitabine and Oxaliplatin); Drug: cetuximab β; Drug: HRS-7058 |
| MSS-KRAS G12D-Adebrelimab | Experimental | Not described Receives: Radiation: Short-course radiotherapy; Drug: XELOX (Capecitabine and Oxaliplatin); Drug: PD-L1 antibody; Drug: HRS-4642 |
| MSS-KRAS G12D-cetuximab β | Experimental | Not described Receives: Radiation: Short-course radiotherapy; Drug: XELOX (Capecitabine and Oxaliplatin); Drug: cetuximab β; Drug: HRS-4642 |
| MSS-CMS | Experimental | Not described Receives: Drug: SHR-1701; Radiation: Short-course radiotherapy; Drug: XELOX (Capecitabine and 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 1 year after the decision of W&W.
Secondary outcomes (10)
Adverse effects rate: proportion of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0.
Measured: From date of stratification to 3 months post-neoadjuvant therapy, an average of 8 months.
Organ preservation rate: proportion of participants who either achieve cCR and choose W&W or achieve cCR/near-cCR and choose local excision, out of the total participants who complete neoadjuvant therapy.
This endpoint is applicable only to patients with locally advanced rectal cancer.
Measured: From date of stratification until the resection of rectum or anus, assessed up to 36 months.
R0 resection rate: proportion of surgical resections with negative margins (proximal, distal, and circumferential) on microscopic examination, with CRM negativity defined as > 1 mm from tumor bed.
Measured: 1 month after the surgery.
Rate of surgical complications: rates of surgical complications such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measured: within 3 months after the surgery.
Treatment compliance: treatment completion rate and delay duration during the treatment period.
Measured: From date of stratification to the completion of neoadjuvant therapy, an average of 5 months.
3 year local recurrence free survival rate: proportion of participants with no tumor recurrence in the primary site (e.g., rectum) or other pelvic regions within 3 years from date of surgery or cCR.
Measured: From date of surgery or cCR until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate: proportion of participants with no distant metastases (e.g., liver, lung) within 3 years from date of stratification.
Measured: From date of stratification until the date of first documented distant metastasis, assessed up to 36 months.
3 year disease free survival rate: proportion of participants with no disease recurrence (including local recurrence and distant metastasis) or death from the disease within 3 years from date of stratification.
Measured: From date of stratification until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year overall survival rate: proportion of participants who are alive at 3 years from date of stratification.
Measured: From date of stratification until the date of death from any cause, assessed up to 36 months.
Quality of life (QoL) score: subjective assessment using validated standardized questionnaires.
Measured: From date of stratification to 3 years post-neoadjuvant therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Colorectal 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
- 134 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
- NCT07503639
- Sponsor's protocol ID
- 2025-697-4846
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes
- ClinicalTrials.gov ID
- NCT07503639
- Acronym / sponsor ID
- 2025-697-4846
- Conditions
- Locally Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 31 Mar 2026 (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 prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MSI-H/dMMR | Experimental | Drug: SHR-1701, Drug: SHR-8068 |
| MSS-KRAS G12C-Adebrelimab | Experimental | Radiation: Short-course radiotherapy, Drug: XELOX (Capecitabine and Oxaliplatin), Drug: PD-L1 antibody, Drug: HRS-7058 |
| MSS-KRAS G12C-cetuximab β | Experimental | Radiation: Short-course radiotherapy, Drug: XELOX (Capecitabine and Oxaliplatin), Drug: cetuximab β, Drug: HRS-7058 |
| MSS-KRAS G12D-Adebrelimab | Experimental | Radiation: Short-course radiotherapy, Drug: XELOX (Capecitabine and Oxaliplatin), Drug: PD-L1 antibody, Drug: HRS-4642 |
| MSS-KRAS G12D-cetuximab β | Experimental | Radiation: Short-course radiotherapy, Drug: XELOX (Capecitabine and Oxaliplatin), Drug: cetuximab β, Drug: HRS-4642 |
| MSS-CMS | Experimental | Drug: SHR-1701, Radiation: Short-course radiotherapy, Drug: XELOX (Capecitabine and Oxaliplatin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old, female and male;
- Pathological confirmed adenocarcinoma;
- Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;
- Treatment-naïve and no distance metastases;
- KPS ≥ 70;
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 |
|---|---|---|
| SHR-17011800mg d1 q3w | Drug | MSI-H/dMMR, MSS-CMS |
| SHR-8068280mg，C1D1 | Drug | MSI-H/dMMR |
| Short-course radiotherapy25Gy/5Fx | Radiation | MSS-CMS, MSS-KRAS G12C-Adebrelimab, MSS-KRAS G12C-cetuximab β, MSS-KRAS G12D-Adebrelimab, MSS-KRAS G12D-cetuximab β |
| XELOX (Capecitabine and Oxaliplatin)Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w | Drug | MSS-CMS, MSS-KRAS G12C-Adebrelimab, MSS-KRAS G12C-cetuximab β, MSS-KRAS G12D-Adebrelimab, MSS-KRAS G12D-cetuximab β |
| PD-L1 antibody1200mg d1 q3w | Drug | MSS-KRAS G12C-Adebrelimab, MSS-KRAS G12D-Adebrelimab |
| cetuximab β250mg/m2 d1, 500mg/m2 d8 q3w | Drug | MSS-KRAS G12C-cetuximab β, MSS-KRAS G12D-cetuximab β |
| HRS-7058200mg bid | Drug | MSS-KRAS G12C-Adebrelimab, MSS-KRAS G12C-cetuximab β |
| HRS-4642500mg d1, 1200mg d8 q3w | Drug | MSS-KRAS G12D-Adebrelimab, MSS-KRAS G12D-cetuximab β |
Primary outcome
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.
Time frame: 1 month after the surgery or 1 year after the decision of W&W.
10 secondary outcomes
Adverse effects rate: proportion of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0.
Time frame: From date of stratification to 3 months post-neoadjuvant therapy, an average of 8 months.
Organ preservation rate: proportion of participants who either achieve cCR and choose W&W or achieve cCR/near-cCR and choose local excision, out of the total participants who complete neoadjuvant therapy.
Time frame: From date of stratification until the resection of rectum or anus, assessed up to 36 months.
R0 resection rate: proportion of surgical resections with negative margins (proximal, distal, and circumferential) on microscopic examination, with CRM negativity defined as > 1 mm from tumor bed.
Time frame: 1 month after the surgery.
Rate of surgical complications: rates of surgical complications such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Time frame: within 3 months after the surgery.
Treatment compliance: treatment completion rate and delay duration during the treatment period.
Time frame: From date of stratification to the completion of neoadjuvant therapy, an average of 5 months.
3 year local recurrence free survival rate: proportion of participants with no tumor recurrence in the primary site (e.g., rectum) or other pelvic regions within 3 years from date of surgery or cCR.
Time frame: From date of surgery or cCR until the date of first documented pelvic failure, assessed up to 36 months.
3 year distant metastasis free survival rate: proportion of participants with no distant metastases (e.g., liver, lung) within 3 years from date of stratification.
Time frame: From date of stratification until the date of first documented distant metastasis, assessed up to 36 months.
3 year disease free survival rate: proportion of participants with no disease recurrence (including local recurrence and distant metastasis) or death from the disease within 3 years from date of stratification.
Time frame: From date of stratification until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year overall survival rate: proportion of participants who are alive at 3 years from date of stratification.
Time frame: From date of stratification until the date of death from any cause, assessed up to 36 months.
Quality of life (QoL) score: subjective assessment using validated standardized questionnaires.
Time frame: From date of stratification to 3 years post-neoadjuvant therapy.
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 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701, SHR-8068 and Short-course radiotherapy in people with Locally Advanced Colorectal 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 8 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: opening soon, as of the sponsor's last update on 31 Mar 2026. 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?
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 (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: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. (time frame: 1 month after the surgery or 1 year after 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 31 Mar 2026.