Advanced Rectal CancerPhase 2NCT07651007

Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

A Phase 2 study testing iTNT-HX02 in people with Advanced Rectal Cancer, run by Wang Xin.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer. The main questions it aims to answer are: 1. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Advanced Rectal Cancer
What is being tested?: iTNT-HX02
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: No sites listed yet
Study dates: 31 May 2026to 31 Dec 2029
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18-70 years;
ECOG PS score: 0-1;
Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing MSS/pMMR status;
Lesion located ≤10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO staging criteria for lower rectal cancer: patients with stage II/III rectal cancer staged by MRI or endorectal ultrasound, who have at least one of the following high-risk factors: cT4a with more than half the circumference of the bowel invaded (measured by MRI), cT4b (resectable), cT3 with tumor penetration ≥5 mm beyond the muscularis propria (T3c/d) and positive extramural venous invasion (EMVI+) (for mid-upper rectal tumors), cN2, MRF+ (≤2 mm); for lower rectal tumors located on the anterior wall, additional criteria include T3 stage and tumor occupying >50% of the bowel circumference; for tumors primarily located on the lateral-posterior wall in the lower rectum, tumor penetration through the bowel wall (internal anal sphincter) ≥5 mm; for tumors invading the external anal sphincter or levator ani muscle (staged as stage IV). Preoperative T staging is based on endorectal ultrasound and rectal MRI; N staging on abdominal CT; M staging on abdominal and chest CT. If symptoms are present, appropriate imaging studies (brain MRI or whole-body bone scan) should be performed. Patients with MRI contraindications may be cautiously included based on CT and endorectal ultrasound staging. All patient staging must be reviewed and confirmed by a multidisciplinary team (MDT).
No evidence of distant metastasis confirmed by comprehensive evaluation;

Show all 12Show fewer

Primary rectal cancer patients who have not received prior surgery (except palliative stoma formation), radiotherapy, systemic chemotherapy, or other anti-tumor treatments before enrollment;
Normal organ function, meeting the following laboratory criteria: Hemoglobin (HB) ≥9 g/dL, white blood cell count (WBC) ≥3.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L. Biochemical tests must meet the following standards: creatinine (Crea) and bilirubin (BIL) ≤1.0×ULN, ALT and AST ≤2.5×ULN, alkaline phosphatase (ALP) ≤2.5×ULN, total bilirubin (Tbil) ≤1.5×ULN;
No history of hypersensitivity to 5-FU class drugs or platinum-based agents;
No prior radiation therapy to the planned irradiation site;
Female participants of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and agree to use an effective method of contraception during the study and for 8 weeks after the last dose. Male participants must agree to use an effective method of contraception during the study and for 8 weeks after the last dose;
Participants must voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up visits.

Who cannot join

Prior pelvic radiotherapy;
Active or progressive infection requiring systemic treatment, such as active tuberculosis or active hepatitis;
Presence of uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, cirrhosis, rheumatological or autoimmune disorders, and severe pulmonary disease;
Clinically significant thyroid dysfunction (based on serum thyroid hormone levels TT4, TT3, FT3, FT4, and serum thyrotropin TSH), deemed unsuitable for study participation by the investigator. (5) History of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or spontaneous major bleeding from tumors;
Prior or concurrent diagnosis of other malignancies (including synchronous colorectal cancer), except for cured cases of cutaneous basal cell carcinoma and cervical carcinoma in situ; (7) Presence of any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, raises concern about the patient's unsuitability for the investigational drug, may interfere with interpretation of study results, or places the patient at high risk; (8) Estimated insufficient compliance of the patient to participate in this clinical study; (9) History of gastrointestinal fistula, perforation, bleeding, severe peptic ulcer disease, or other serious gastrointestinal disorders; (10) Patients who have undergone solid organ or bone marrow transplantation, or those who have had an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xin Wang contact

02885423609

wangxin@wchscu.edu.cn

About this study

Official title: A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

The main questions it aims to answer are:

Does this regimen increase the complete response rate ?
What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation.

Participants will:

Receive short-course radiotherapy (25Gy/5f) over 5 consecutive days.
Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months).
Regular checkups and tests during treatment.
Keep a diary of their symptoms and the number of times they use a rescue inhaler.

Conditions: Advanced Rectal Cancer
Being tested: iTNT-HX02

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iTNT-HX02Drug
short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy

Study groups in NCT07651007
Study group	Role	What they receive
Experimental arm	Experimental	Not described Receives: Drug: iTNT-HX02

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete response rate
Measured: From enrollment to one year after surgery or drug treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202631 Dec 2029

First posted16 Jun 2026
Study start31 May 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Advanced Rectal CancerStudies of the same condition, open and under way.
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: 29 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07651007
Sponsor's protocol ID: iTNT-HX02
Status last verified: Jun 2026
First submitted: 11 Jun 2026
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
PubMed 33862000
Zhu J, Liu A, Sun X, Liu L, Zhu Y, Zhang T, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, Zhao Y, Cai G, Zhang W, Xia F, Wan J, Zhang H, Shen L, Cai S, Zhang Z. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer. J Clin Oncol. 2020 Dec 20;38(36):4231-4239. doi: 10.1200/JCO.20.01932. Epub 2020 Oct 29.
PubMed 33119477
Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.
PubMed 35263150
Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
PubMed 33301740
Cisel B, Pietrzak L, Michalski W, Wyrwicz L, Rutkowski A, Kosakowska E, Cencelewicz A, Spalek M, Polkowski W, Jankiewicz M, Stylinski R, Bebenek M, Kapturkiewicz B, Maciejczyk A, Sadowski J, Zygulska J, Zegarski W, Jankowski M, Las-Jankowska M, Toczko Z, Zelazowska-Omiotek U, Kepka L, Socha J, Wasilewska-Tesluk E, Markiewicz W, Kladny J, Majewski A, Kapuscinski W, Suwinski R, Bujko K; Polish Colorectal Study Group. Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study. Ann Oncol. 2019 Aug 1;30(8):1298-1303. doi: 10.1093/annonc/mdz186.
PubMed 31192355
Yu Y, Li Y, Xu C, Zhang Z, Zhang X. Comparison of long course and short course preoperative radiotherapy in the treatment of locally advanced rectal cancer: a systematic review and meta-analysis. Rev Esp Enferm Dig. 2019 Jan;111(1):17-27. doi: 10.17235/reed.2018.5674/2018.
PubMed 30284906
Diefenhardt M, Martin D, Fleischmann M, Hofheinz RD, Ghadimi M, Rodel C, Fokas E. Overall Survival After Treatment Failure Among Patients With Rectal Cancer. JAMA Netw Open. 2023 Oct 2;6(10):e2340256. doi: 10.1001/jamanetworkopen.2023.40256.
PubMed 37902752

Interested in taking part?

Xin Wang

02885423609

wangxin@wchscu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Advanced Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR
ClinicalTrials.gov ID: NCT07651007
Acronym / sponsor ID: iTNT-HX02
Conditions: Advanced Rectal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 29 participants (estimated)
Lead sponsor: Wang XinUniversity, hospital or other
Study start: 31 May 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 16 Jun 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.

The main questions it aims to answer are:

Does this regimen increase the complete response rate ?
What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation.

Participants will:

Receive short-course radiotherapy (25Gy/5f) over 5 consecutive days.
Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months).
Regular checkups and tests during treatment.
Keep a diary of their symptoms and the number of times they use a rescue inhaler.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental arm	Experimental	Drug: iTNT-HX02

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age: 18-70 years;
ECOG PS score: 0-1;
Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing MSS/pMMR status;
Lesion located ≤10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO staging criteria for lower rectal cancer: patients with stage II/III rectal cancer staged by MRI or endorectal ultrasound, who have at least one of the following high-risk factors: cT4a with more than half the circumference of the bowel invaded (measured by MRI), cT4b (resectable), cT3 with tumor penetration ≥5 mm beyond the muscularis propria (T3c/d) and positive extramural venous invasion (EMVI+) (for mid-upper rectal tumors), cN2, MRF+ (≤2 mm); for lower rectal tumors located on the anterior wall, additional criteria include T3 stage and tumor occupying >50% of the bowel circumference; for tumors primarily located on the lateral-posterior wall in the lower rectum, tumor penetration through the bowel wall (internal anal sphincter) ≥5 mm; for tumors invading the external anal sphincter or levator ani muscle (staged as stage IV). Preoperative T staging is based on endorectal ultrasound and rectal MRI; N staging on abdominal CT; M staging on abdominal and chest CT. If symptoms are present, appropriate imaging studies (brain MRI or whole-body bone scan) should be performed. Patients with MRI contraindications may be cautiously included based on CT and endorectal ultrasound staging. All patient staging must be reviewed and confirmed by a multidisciplinary team (MDT).

Key exclusion criteria (5 listed)

Prior pelvic radiotherapy;
Active or progressive infection requiring systemic treatment, such as active tuberculosis or active hepatitis;
Presence of uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, cirrhosis, rheumatological or autoimmune disorders, and severe pulmonary disease;
Clinically significant thyroid dysfunction (based on serum thyroid hormone levels TT4, TT3, FT3, FT4, and serum thyrotropin TSH), deemed unsuitable for study participation by the investigator. (5) History of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or spontaneous major bleeding from tumors;
Prior or concurrent diagnosis of other malignancies (including synchronous colorectal cancer), except for cured cases of cutaneous basal cell carcinoma and cervical carcinoma in situ; (7) Presence of any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, raises concern about the patient's unsuitability for the investigational drug, may interfere with interpretation of study results, or places the patient at high risk; (8) Estimated insufficient compliance of the patient to participate in this clinical study; (9) History of gastrointestinal fistula, perforation, bleeding, severe peptic ulcer disease, or other serious gastrointestinal disorders; (10) Patients who have undergone solid organ or bone marrow transplantation, or those who have had an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.

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
iTNT-HX02short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy	Drug	Experimental arm

Primary outcome

Complete response rate
Time frame: From enrollment to one year after surgery or drug treatment

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 16 Jun 2026.
Results publication: PubMed 33862000Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
Results publication: PubMed 33119477Zhu J, Liu A, Sun X, Liu L, Zhu Y, Zhang T, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, Zhao Y, Cai G, Zhang W, Xia F, Wan J, Zhang H, Shen L, Cai S, Zhang Z. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer. J Clin Oncol. 2020 Dec 20;38(36):4231-4239. doi: 10.1200/JCO.20.01932. Epub 2020 Oct 29.
Results publication: PubMed 35263150Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.
Results publication: PubMed 33301740Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
Results publication: PubMed 31192355Cisel B, Pietrzak L, Michalski W, Wyrwicz L, Rutkowski A, Kosakowska E, Cencelewicz A, Spalek M, Polkowski W, Jankiewicz M, Stylinski R, Bebenek M, Kapturkiewicz B, Maciejczyk A, Sadowski J, Zygulska J, Zegarski W, Jankowski M, Las-Jankowska M, Toczko Z, Zelazowska-Omiotek U, Kepka L, Socha J, Wasilewska-Tesluk E, Markiewicz W, Kladny J, Majewski A, Kapuscinski W, Suwinski R, Bujko K; Polish Colorectal Study Group. Long-course preoperative chemoradiation versus 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study. Ann Oncol. 2019 Aug 1;30(8):1298-1303. doi: 10.1093/annonc/mdz186.
Results publication: PubMed 30284906Yu Y, Li Y, Xu C, Zhang Z, Zhang X. Comparison of long course and short course preoperative radiotherapy in the treatment of locally advanced rectal cancer: a systematic review and meta-analysis. Rev Esp Enferm Dig. 2019 Jan;111(1):17-27. doi: 10.17235/reed.2018.5674/2018.
Results publication: PubMed 37902752Diefenhardt M, Martin D, Fleischmann M, Hofheinz RD, Ghadimi M, Rodel C, Fokas E. Overall Survival After Treatment Failure Among Patients With Rectal Cancer. JAMA Netw Open. 2023 Oct 2;6(10):e2340256. doi: 10.1001/jamanetworkopen.2023.40256.
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.

Xin Wang contact

02885423609

wangxin@wchscu.edu.cn

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing iTNT-HX02 in people with Advanced Rectal Cancer, run by Wang Xin.

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 12 inclusion and 5 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 16 Jun 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 Xin Wang (02885423609, wangxin@wchscu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: From enrollment to one year after surgery or drug treatment). 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 NCT07651007, which also lists 7 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 16 Jun 2026.