Colon CancerPhase 2NITDCNCT06215677
Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer
A Phase 2 study testing Camrelizumab in people with Colon Cancer and Mismatch Repair Deficiency, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, Mismatch Repair Deficiency, Immunotherapy
- What is being tested?
- Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2024to 10 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- ECOG score 0-2;
- Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
- Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
- Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
- No evidence of distant metastasis;
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- Newly treated patients who have not received treatment including chemotherapy and surgery;
- Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
- Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.
Who cannot join
- A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
- Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
- Patients with a history of severe mental illness, immune disease, hormone medication;
- Patients contraindicated by immunotherapy or surgery;
- Participated in other clinical researchers in the past 3 months;
- Any other circumstances that the investigator considers inappropriate for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Peking Union Medical College Hospital
Beijing
About this study
Official title: Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
- Conditions
- Colon Cancer, Mismatch Repair Deficiency, Immunotherapy
- Being tested
- Camrelizumab
- Medical subject headings
- Colonic Neoplasms, Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant immunotherapy | Experimental | Not described Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of R0 resection
No tumor infiltration within 1 mm of the surgical margins
Measured: Tumour specimen evaluated within 2 weeks after surgery
Secondary outcomes (4)
Pathological complete response (pCR)
Number of patients with pCR evaluated according to the Mandard tumour regression grading system
Measured: Tumour specimen evaluated within 2 weeks after surgery.
diesease-free survival
No tumor regrowth or recurrence or metastasis found
Measured: 3 years
overall survival
Refers to the proportion of patients still alive at 5 years after surgery
Measured: 5 years
Safety and tolerability of Camrelizumab administered
Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0
Measured: Up to approximately 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jan 2024
- Primary completion10 May 2025
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIAO Yi, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215677
- Sponsor's protocol ID
- K5121
- Acronym
- NITDC
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT06215677
- Acronym / sponsor ID
- NITDC / K5121
- Conditions
- Colon Cancer, Mismatch Repair Deficiency, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 22 Jan 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.
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant immunotherapy | Experimental | Drug: Camrelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-75 years;
- ECOG score 0-2;
- Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
- Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
- Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
Key exclusion criteria (6 listed)
- A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
- Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
- Patients with a history of severe mental illness, immune disease, hormone medication;
- Patients contraindicated by immunotherapy or surgery;
- Participated in other clinical researchers in the past 3 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 |
|---|---|---|
| CamrelizumabCamrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon. | Drug | Neoadjuvant immunotherapy |
Primary outcome
the rate of R0 resection
Time frame: Tumour specimen evaluated within 2 weeks after surgery
No tumor infiltration within 1 mm of the surgical margins
4 secondary outcomes
Pathological complete response (pCR)
Time frame: Tumour specimen evaluated within 2 weeks after surgery.
diesease-free survival
Time frame: 3 years
overall survival
Time frame: 5 years
Safety and tolerability of Camrelizumab administered
Time frame: Up to approximately 9 weeks
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 21 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Camrelizumab in people with Colon Cancer and Mismatch Repair Deficiency, run by Peking Union Medical College Hospital at 2 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 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
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?
the rate of R0 resection (time frame: Tumour specimen evaluated within 2 weeks after surgery). 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 21 Jul 2026.