Rectal Cancer PatientsPhase 2NCT07521605
Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer
A Phase 2 study testing Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI) and Capecitabine in people with Rectal Cancer Patients, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI) and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 31 Dec 2034
- 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 to 75 years, male or female.
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods.
- Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system.
- The lower edge of the tumor is located within 10 cm from the anal verge (defined as low/mid rectal cancer).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow, hepatic, and renal function, defined as: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L，Platelet count ≥ 100 x 10⁹/L，Hemoglobin ≥ 90 g/L，Total Bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN)，Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 x ULN，Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula)
- Voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up procedures.
Who cannot join
- Evidence of distant metastasis (M1 disease) on baseline imaging.
- Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer.
- History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment.
- Any of the following uncontrolled conditions or comorbidities:
- 1）Severe active infection requiring systemic therapy. 2）Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 months.
- 3）Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that would compromise the ability to provide informed consent or comply with study procedures.
Show all 10Show fewer
- 5. Known history of severe immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids at doses > 10mg/day prednisone equivalent) within the past 2 years.
- 6. Known history of hypersensitivity to any component of the study drugs (Liposomal Irinotecan, Capecitabine, Camrelizumab) or history of severe hypersensitivity reactions to other monoclonal antibodies.
- 7. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 6 months after the last dose of study treatment.
- 8. Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or adherence to the protocol (e.g., inability to swallow oral medications, active gastrointestinal bleeding, intestinal obstruction).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Yong Li, Prof., 020-83827812-60911, liyong@gdph.org.cn
About this study
Official title: Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol
This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum.
The main things you will do in this study are:
Read more
- Receive a Short Course of Radiation Therapy (5 treatments over 1 week).
- After a 1-week break, receive a combination of three drugs:
1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded.
The most important goal of this research is to see how many patients achieve a "Complete Response," which means:
- No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or
- No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a "Watch and Wait" strategy (Clinical Complete Response, cCR).
Researchers will also monitor:
- The safety of the treatment and its side effects.
- How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence).
- The rate of successful tumor removal and the rate of preserving the anus.
- Conditions
- Rectal Cancer Patients
- Being tested
- Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI), Capecitabine, Camrelizumab
- Keywords
- Locally advanced rectal cancer, pMMR/MSS, Short-course radiotherapy, Liposomal irinotecan, Neoadjuvant immunochemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Course RadiotherapyRadiation
Short-course radiotherapy is a radiation therapy regimen delivered over a condensed period. In this study, patients will receive a total dose of 25 Gray (Gy), administered in 5 fractions (5 Gy per fraction), delivered once daily over five consecutive days. This intervention constitutes the initial phase of the neoadjuvant treatment protocol.
Liposomal Irinotecan (nal-IRI)Drug
Liposomal irinotecan is a nanoliposomal formulation of the chemotherapeutic agent irinotecan, designed to enhance tumor drug delivery and reduce systemic toxicity. In this study, it will be administered intravenously at a dose of 60 mg/m² on Day 1 of each 21-day cycle, for a total of 8 cycles, following the completion of short-course radiotherapy.
CapecitabineDrug
Capecitabine is an oral fluoropyrimidine carbamate prodrug that is converted to 5-fluorouracil in the body. In this study, it will be administered orally at a dose of 1000 mg/m² twice daily (BID) from Days 1 to 14 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and camrelizumab.
CamrelizumabDrug
Camrelizumab is a humanized monoclonal antibody that targets the programmed cell death-1 (PD-1) receptor on immune cells, functioning as an immune checkpoint inhibitor. In this study, it will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Therapy Arm | Experimental | Not described Receives: Radiation: Short-Course Radiotherapy; Drug: Liposomal Irinotecan (nal-IRI); Drug: Capecitabine; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The primary endpoint is the Complete Response (CR) rate after completion of neoadjuvant therapy, which is a composite of pathological complete response (pCR) and clinical complete response (cCR).
- pCR is defined as the absence of viable tumor cells in the surgical specimen (TRG1a according to the Becker tumor regression grading system) in patients who undergo surgery.
- cCR is defined as the achievement of a ycT0N0 status, assessed by clinical evaluations (including digital rectal exam, endoscopy, MRI, etc.), in patients who enter a "Watch and Wait" strategy without immediate surgery.
Measured: From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks.
Secondary outcomes (7)
3 year Disease-Free Survival
Defined as the time from the start of treatment until disease recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: 3 years from the start of treatment.
3 year Overall Survival
Defined as the time from the start of treatment until death from any cause.
Measured: 3 years from the start of treatment.
Objective Response Rate
Defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST 1.1 criteria.
Measured: From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks.
R0 Resection Rate
Defined as the proportion of patients who undergo surgery and achieve a microscopically negative margin resection (R0 resection).
Measured: Assessed at the time of surgery following neoadjuvant therapy, over a period of approximately 24-30 weeks from the start of treatment.
Tumor Regression Grade
Assessed on the surgical specimen using the Becker grading system: TRG 1a (complete response), TRG 1b (<10% residual), TRG 2 (10%-50% residual), TRG 3 (>50% residual).
Measured: Assessed during pathological evaluation after surgery, over a period of approximately 24-30 weeks from the start of treatment.
Sphincter Preservation Rate
Defined as the proportion of patients undergoing radical surgery who successfully retain anal sphincter function (without a permanent colostomy).
Measured: Confirmed immediately after surgery, over a period of approximately 24-30 weeks from the start of treatment.
Incidence of Treatment-Related Adverse Events
The incidence and severity of treatment-related adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From the time of informed consent until 30 days after the last dose of study treatment, assessed over a period of approximately 28-31 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521605
- Sponsor's protocol ID
- neoNRCC
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang Y, Pang K, Lin G, Liu X, Gao J, Zhou J, Xu L, Gao Z, Wu Y, Li A, Han J, Wu G, Wang X, Li F, Ye Y, Zhang J, Chen G, Wang H, Kong Y, Wu A, Xiao Y, Yao H, Zhang Z. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial. Nat Med. 2025 Feb;31(2):449-456. doi: 10.1038/s41591-024-03360-5. Epub 2025 Jan 6.
PubMed 39762418Rahma OE, Yothers G, Hong TS, Russell MM, You YN, Parker W, Jacobs SA, Colangelo LH, Lucas PC, Gollub MJ, Hall WA, Kachnic LA, Vijayvergia N, O'Rourke MA, Faller BA, Valicenti RK, Schefter TE, George S, Kainthla R, Stella PJ, Sigurdson E, Wolmark N, George TJ. Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1225-1230. doi: 10.1001/jamaoncol.2021.1683.
PubMed 34196693Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
PubMed 26615328Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, El Dika IH, Segal N, Shcherba M, Sugarman R, Stadler Z, Yaeger R, Smith JJ, Rousseau B, Argiles G, Patel M, Desai A, Saltz LB, Widmar M, Iyer K, Zhang J, Gianino N, Crane C, Romesser PB, Pappou EP, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser MR, Schalper KA, Diaz LA Jr. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022 Jun 23;386(25):2363-2376. doi: 10.1056/NEJMoa2201445. Epub 2022 Jun 5.
PubMed 35660797Cui J, Qin S, Zhou Y, Zhang S, Sun X, Zhang M, Cui J, Fang W, Gu K, Li Z, Wang J, Chen X, Yao J, Zhou J, Wang G, Bai Y, Xiao J, Qiu W, Wang B, Xia T, Wang C, Kong L, Yin J, Zhang T, Shen X, Fu D, Gao C, Wang H, Wang Q, Wang L. Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther. 2024 Sep 19;9(1):248. doi: 10.1038/s41392-024-01948-4.
PubMed 39300077Lee YM, Chen YH, Ou DL, Hsu CL, Liu JH, Ko JY, Hu MC, Tan CT. SN-38, an active metabolite of irinotecan, enhances anti-PD-1 treatment efficacy in head and neck squamous cell carcinoma. J Pathol. 2023 Apr;259(4):428-440. doi: 10.1002/path.6055. Epub 2023 Feb 24.
PubMed 36641765Chung YM, Khan PP, Wang H, Tsai WB, Qiao Y, Yu B, Larrick JW, Hu MC. Sensitizing tumors to anti-PD-1 therapy by promoting NK and CD8+ T cells via pharmacological activation of FOXO3. J Immunother Cancer. 2021 Dec;9(12):e002772. doi: 10.1136/jitc-2021-002772.
PubMed 34887262Zhu 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 33119477Conroy 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 33862000Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709.
PubMed 29590544Pachman DR, Qin R, Seisler DK, Smith EM, Beutler AS, Ta LE, Lafky JM, Wagner-Johnston ND, Ruddy KJ, Dakhil S, Staff NP, Grothey A, Loprinzi CL. Clinical Course of Oxaliplatin-Induced Neuropathy: Results From the Randomized Phase III Trial N08CB (Alliance). J Clin Oncol. 2015 Oct 20;33(30):3416-22. doi: 10.1200/JCO.2014.58.8533. Epub 2015 Aug 17.
PubMed 26282635Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
PubMed 19451431Kamrava M, Bernstein MB, Camphausen K, Hodge JW. Combining radiation, immunotherapy, and antiangiogenesis agents in the management of cancer: the Three Musketeers or just another quixotic combination? Mol Biosyst. 2009 Nov;5(11):1262-70. doi: 10.1039/b911313b. Epub 2009 Aug 27.
PubMed 19823740Ye JX, Liu Y, Qin Y, Zhong HH, Yi WN, Shi XY. KRAS and BRAF gene mutations and DNA mismatch repair status in Chinese colorectal carcinoma patients. World J Gastroenterol. 2015 Feb 7;21(5):1595-605. doi: 10.3748/wjg.v21.i5.1595.
PubMed 25663779Jin 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol
- ClinicalTrials.gov ID
- NCT07521605
- Acronym / sponsor ID
- neoNRCC
- Conditions
- Rectal Cancer Patients
- Keywords
- Locally advanced rectal cancer, pMMR/MSS, Short-course radiotherapy, Liposomal irinotecan, Neoadjuvant immunochemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 13 Apr 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 study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum.
The main things you will do in this study are:
- Receive a Short Course of Radiation Therapy (5 treatments over 1 week).
- After a 1-week break, receive a combination of three drugs:
1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded.
The most important goal of this research is to see how many patients achieve a "Complete Response," which means:
- No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or
- No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a "Watch and Wait" strategy (Clinical Complete Response, cCR).
Researchers will also monitor:
- The safety of the treatment and its side effects.
- How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence).
- The rate of successful tumor removal and the rate of preserving the anus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Therapy Arm | Experimental | Radiation: Short-Course Radiotherapy, Drug: Liposomal Irinotecan (nal-IRI), Drug: Capecitabine, Drug: Camrelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 75 years, male or female.
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods.
- Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system.
- The lower edge of the tumor is located within 10 cm from the anal verge (defined as low/mid rectal cancer).
Key exclusion criteria (10 listed)
- Evidence of distant metastasis (M1 disease) on baseline imaging.
- Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer.
- History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment.
- Any of the following uncontrolled conditions or comorbidities:
- 1）Severe active infection requiring systemic therapy. 2）Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 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 |
|---|---|---|
| Short-Course RadiotherapyShort-course radiotherapy is a radiation therapy regimen delivered over a condensed period. In this study, patients will receive a total dose of 25 Gray (Gy), administered in 5 fractions (5 Gy per fraction), delivered once daily over five consecutive days. This intervention constitutes the initial phase of the neoadjuvant treatment protocol. | Radiation | Neoadjuvant Therapy Arm |
| Liposomal Irinotecan (nal-IRI)Liposomal irinotecan is a nanoliposomal formulation of the chemotherapeutic agent irinotecan, designed to enhance tumor drug delivery and reduce systemic toxicity. In this study, it will be administered intravenously at a dose of 60 mg/m² on Day 1 of each 21-day cycle, for a total of 8 cycles, following the completion of short-course radiotherapy. | Drug | Neoadjuvant Therapy Arm |
| CapecitabineCapecitabine is an oral fluoropyrimidine carbamate prodrug that is converted to 5-fluorouracil in the body. In this study, it will be administered orally at a dose of 1000 mg/m² twice daily (BID) from Days 1 to 14 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and camrelizumab. | Drug | Neoadjuvant Therapy Arm |
| CamrelizumabCamrelizumab is a humanized monoclonal antibody that targets the programmed cell death-1 (PD-1) receptor on immune cells, functioning as an immune checkpoint inhibitor. In this study, it will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and capecitabine. | Drug | Neoadjuvant Therapy Arm |
Primary outcome
Complete Response Rate
Time frame: From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks.
The primary endpoint is the Complete Response (CR) rate after completion of neoadjuvant therapy, which is a composite of pathological complete response (pCR) and clinical complete response (cCR). 1. pCR is defined as the absence of viable tumor cells in the surgical specimen (TRG1a according to the Becker tumor regression grading system) in patients who undergo surgery. 2. cCR is defined as the achievement of a ycT0N0 status, assessed by clinical evaluations (including digital rectal exam, endoscopy, MRI, etc.), in patients who enter a "Watch and Wait" strategy without immediate surgery.
7 secondary outcomes
3 year Disease-Free Survival
Time frame: 3 years from the start of treatment.
3 year Overall Survival
Time frame: 3 years from the start of treatment.
Objective Response Rate
Time frame: From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks.
R0 Resection Rate
Time frame: Assessed at the time of surgery following neoadjuvant therapy, over a period of approximately 24-30 weeks from the start of treatment.
Tumor Regression Grade
Time frame: Assessed during pathological evaluation after surgery, over a period of approximately 24-30 weeks from the start of treatment.
Sphincter Preservation Rate
Time frame: Confirmed immediately after surgery, over a period of approximately 24-30 weeks from the start of treatment.
Incidence of Treatment-Related Adverse Events
Time frame: From the time of informed consent until 30 days after the last dose of study treatment, assessed over a period of approximately 28-31 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 13 Apr 2026.
- Background: PubMed 39762418Yang Y, Pang K, Lin G, Liu X, Gao J, Zhou J, Xu L, Gao Z, Wu Y, Li A, Han J, Wu G, Wang X, Li F, Ye Y, Zhang J, Chen G, Wang H, Kong Y, Wu A, Xiao Y, Yao H, Zhang Z. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial. Nat Med. 2025 Feb;31(2):449-456. doi: 10.1038/s41591-024-03360-5. Epub 2025 Jan 6.
- Background: PubMed 34196693Rahma OE, Yothers G, Hong TS, Russell MM, You YN, Parker W, Jacobs SA, Colangelo LH, Lucas PC, Gollub MJ, Hall WA, Kachnic LA, Vijayvergia N, O'Rourke MA, Faller BA, Valicenti RK, Schefter TE, George S, Kainthla R, Stella PJ, Sigurdson E, Wolmark N, George TJ. Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1225-1230. doi: 10.1001/jamaoncol.2021.1683.
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- 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.
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 Short-Course Radiotherapy, Liposomal Irinotecan (nal-IRI) and Capecitabine in people with Rectal Cancer Patients, run by Guangdong Provincial People's 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 10 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 13 Apr 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?
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 Deqing Wu, Dr. (020 83827812 60910, wudeqing@gdph.org.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 the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 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 NCT07521605, which also lists 23 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 13 Apr 2026.