Locally Advanced Rectal CancerPhase 2NCT07057089
Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
A Phase 2 study testing Capecitabine, Camrelizumab and CAPOX in people with Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Capecitabine, Camrelizumab and CAPOX
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Dec 2030
- 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
- Age ≥18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
- Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
- The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;
- Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90g/L; 2)Liver and kidney function: ALT/AST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL/min (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)；
- Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;
- Voluntary written informed consent and commitment to complete the full treatment and follow-up program.
Who cannot join
- Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
- Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
- Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension >160/100 mmHg)；
- History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；
- Uncontrolled diabetes mellitus (HbA1c > 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；
- Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)
The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Capecitabine, Camrelizumab, CAPOX, Involve-field irradiation, Elective nodal irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Capecitabine: 825mg/m2, bid;
CamrelizumabDrug
Camrelizumab: 200mg
CAPOXDrug
CAPOX
Involve-field irradiationRadiation
Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region
Elective nodal irradiationRadiation
Elective nodal irradiation: Large pelvic field
TME surgeryProcedure or surgery
TME surgery
| Study group | Role | What they receive |
|---|---|---|
| Involve-field radiotherapy-TNT+Camrelizumab | Experimental | Patients received Involve-field radiotherapy (25Gy/5f, including the primary rectal tumor, metastatic or suspected pelvic lymph nodes, mesorectal, and presacral regions). Four cycles of CAPOX plus Carilizumab were given to patients 1-2 weeks after chemoradiotherapy completion.
Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy combined with camrelizumab. Receives: Drug: Camrelizumab; Drug: CAPOX; Radiation: Involve-field irradiation; Procedure: TME surgery |
| Elective nodal irradiation-TNT | Other | Patients received elective nodal long-course concurrent chemoradiotherapy (50.4 Gy/28f). Capecitabine (825 mg/m² bid) was administered orally on radiotherapy days. Four cycles of CAPOX were given to patients 1-2 weeks after chemoradiotherapy completion.
Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy. Receives: Drug: Capecitabine; Drug: CAPOX; Radiation: Elective nodal irradiation; Procedure: TME surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
CR defined as patient achieving pCR and cCR.
Measured: within 5 weeks
Secondary outcomes (7)
MPR rate
MPR defined as patients achieving a major pathological response after surgery.
Measured: within 3 weeks after surgery
R0-resection rate
R0-resection defined as patients without tumor cell infiltration in the tissue 1mm from the resection margin
Measured: within 3 weeks after surgery
Preservation rate of adjacent invaded organs
The involved organs were successfully preserved during the operation
Measured: within 3 weeks after surgery
ORR
Defined as the percentage of complete response (CR) and partial response (PR) to tumor volume reduction according to RECIST v1.1 criteria
Measured: within 5 weeks
3-year Event Free Survival
EFS defined as time from randomization to objectively observed tumor progression (local recurrence, new disease, or distant metastasis), development of a second malignancy, or death (death from any cause).
Measured: 3 years
3-year OS
OS defined as time from randomization to death from any cause.
Measured: 3 years
Incidence of adverse reactions
Occurrence of adverse reactions during therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Why it stopped: Suspended due to lack of drug supply: the manufacturer ceased to provide investigational drug supply.
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 Hebei Medical University Fourth 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fengpeng Wu, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057089
- Sponsor's protocol ID
- ARK-Rectal cancer-001
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)
- ClinicalTrials.gov ID
- NCT07057089
- Acronym / sponsor ID
- ARK-Rectal cancer-001
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended due to lack of drug supply: the manufacturer ceased to provide investigational drug supply.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Jul 2025 (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 purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involve-field radiotherapy-TNT+Camrelizumab | Experimental | Drug: Camrelizumab, Drug: CAPOX, Radiation: Involve-field irradiation, Procedure: TME surgeryPatients received Involve-field radiotherapy (25Gy/5f, including the primary rectal tumor, metastatic or suspected pelvic lymph nodes, mesorectal, and presacral regions). Four cycles of CAPOX plus Carilizumab were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy combined with camrelizumab. |
| Elective nodal irradiation-TNT | Other | Drug: Capecitabine, Drug: CAPOX, Radiation: Elective nodal irradiation, Procedure: TME surgeryPatients received elective nodal long-course concurrent chemoradiotherapy (50.4 Gy/28f). Capecitabine (825 mg/m² bid) was administered orally on radiotherapy days. Four cycles of CAPOX were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
- Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
- The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;
Key exclusion criteria (8 listed)
- Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
- Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
- Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension >160/100 mmHg)；
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 |
|---|---|---|
| CapecitabineCapecitabine: 825mg/m2, bid; | Drug | Elective nodal irradiation-TNT |
| CamrelizumabCamrelizumab: 200mg | Drug | Involve-field radiotherapy-TNT+Camrelizumab |
| CAPOXCAPOX | Drug | Elective nodal irradiation-TNT, Involve-field radiotherapy-TNT+Camrelizumab |
| Involve-field irradiationInvolve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region | Radiation | Involve-field radiotherapy-TNT+Camrelizumab |
| Elective nodal irradiationElective nodal irradiation: Large pelvic field | Radiation | Elective nodal irradiation-TNT |
| TME surgeryTME surgery | Procedure or surgery | Elective nodal irradiation-TNT, Involve-field radiotherapy-TNT+Camrelizumab |
Primary outcome
CR rate
Time frame: within 5 weeks
CR defined as patient achieving pCR and cCR.
7 secondary outcomes
MPR rate
Time frame: within 3 weeks after surgery
R0-resection rate
Time frame: within 3 weeks after surgery
Preservation rate of adjacent invaded organs
Time frame: within 3 weeks after surgery
ORR
Time frame: within 5 weeks
3-year Event Free Survival
Time frame: 3 years
3-year OS
Time frame: 3 years
Incidence of adverse reactions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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. This study is not recruiting at the moment.
Fengpeng Wu principal investigator
Hebei Medical University Fourth Hospital
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 Capecitabine, Camrelizumab and CAPOX in people with Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth Hospital 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 8 inclusion and 8 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: paused, as of the sponsor's last update on 31 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 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?
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?
CR rate (time frame: within 5 weeks). 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 Jul 2026.