Rcctal CancerPhase 2NCT06808412

To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer

A Phase 2 study testing sintilimab combined with bevacizumab and XELOX in people with Rcctal Cancer, run by xiaohua li at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rcctal Cancer
What is being tested?: sintilimab combined with bevacizumab and XELOX
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 1 siteChina
Study dates: 5 Jul 2024to 5 Jun 2025
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

Cohort A:
Rectal cancer patients who have previously received perioperative XELOX regimen treatment.
Cohort B:
1.Signed written informed consent prior to any trial-related procedures;
2.Non-bedridden cases, regardless of gender, aged 18-75 years;
3.Pathologically confirmed rectal adenocarcinoma, excluding anal squamous cell carcinoma;

Show all 22Show fewer

4.No prior antitumor treatment for rectal cancer. For those with Lynch syndrome, no antitumor treatment has been administered for the colorectal cancer related to this diagnosis;
5.Based on high-resolution MRI, classified as T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the levator ani muscle; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancerous nodules;
6.ECOG performance status of 0-1;
7.Expected survival time > 3 months;
8.Adequate organ function, with subjects meeting the following laboratory criteria:
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without using granulocyte colony-stimulating factor in the past 14 days.
Platelet count ≥ 100 x 10^9/L without transfusion in the past 14 days.
Hemoglobin > 9 g/dL without transfusion or use of erythropoietin in the past 14 days;
Total bilirubin ≤ 1.5 × upper limit of normal (ULN); if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN, enrollment is also allowed;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastases are allowed if ALT or AST ≤ 5 × ULN);
Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 ml/min;
Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN;
Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, subjects can still be enrolled if total T3 (or FT3) and FT4 are within normal range;
Normal levels of cardiac enzyme profile (subjects may still be enrolled if the investigator judges the laboratory abnormality to be of no clinical significance); (optional)
9.For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of the investigational drug (Day 1 of Cycle 1) with a negative result. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential females are defined as those who have been postmenopausal for at least one year, or have undergone surgical sterilization or hysterectomy;
10.If there is a risk of conception, all subjects (regardless of gender) must use contraception with a failure rate of less than 1% throughout the treatment period and until 120 days after the last dose of the investigational drug (or 180 days after the last dose of chemotherapy).

Who cannot join

1. Diagnosed with malignant diseases other than rectal cancer within 5 years prior to the first administration (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely excised in situ carcinoma); 2.Currently participating in an interventional clinical study treatment, or received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 3.Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulus or co-inhibitory T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 4.Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first administration.
5.Experienced active autoimmune diseases requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first administration. Alternative therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;
6.Receiving systemic glucocorticoid treatment within 7 days prior to the first administration of the study (excluding nasal, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy;
Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed;
7.Presence of clinically uncontrollable abdominal effusion (patients who do not require drainage of effusion or who have not shown significant increase in effusion after stopping drainage for 3 days may be included);
8.Known history of allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation;

Show all 28Show fewer

9.Known allergy to the study drugs sintilimab, bevacizumab, or any active ingredients or excipients related to these investigational drugs;
10.Presence of multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and bowel obstruction);
11.Not fully recovered from any toxicity and/or complications arising from any intervention prior to the start of treatment (i.e., ≤ grade 1 or return to baseline, excluding fatigue or hair loss);
12.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies);
13.Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copies exceeding the upper limit of normal for the testing laboratory at the study site);
Note: Hepatitis B subjects meeting the following criteria may also be included:
HBV viral load <1000 copies/ml (200 IU/ml) prior to the first administration; subjects should receive anti-HBV treatment throughout the study drug treatment period to prevent viral reactivation.
Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment but require close monitoring for viral reactivation.
14.Active HCV infection subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 15.Received live vaccine within 30 days prior to the first administration (Cycle 1, Day 1); Note: Inactivated virus vaccine for seasonal influenza is allowed within 30 days prior to the first administration; however, intranasal live attenuated influenza vaccine is not permitted.
16.Pregnant or breastfeeding women; 17.Presence of any severe or uncontrolled systemic diseases, such as:
Significant abnormalities in rhythm, conduction, or morphology on resting ECG that are severe and symptomatic, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation;
Unstable angina, congestive heart failure, chronic heart failure classified as NYHA class ≥ 2;
History of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
Poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to the first administration, or current clinically active interstitial lung disease;
Active pulmonary tuberculosis;
Presence of active or uncontrolled infections requiring systemic treatment; Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); Urinalysis indicating urine protein ≥ ++, confirmed by 24-hour urine protein quantification > 1.0 g;
Presence of mental disorders and inability to cooperate with treatment;
Any history or evidence of disease that may interfere with study results, hinder subject participation throughout the study, abnormal treatment or laboratory test values, or other conditions deemed unsuitable for enrollment by the investigator due to potential risks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

wang contact

86-13201793393

wangyannian001@qq.com

China1 site, 1 recruiting

Xijing Hospital
Xi'an, Shaanxi, 710032
wang, 86-13201793393, wangyannian001@qq.com
Recruiting

Other trials in China

About this study

Official title: A Study on the Efficacy and Safety of Sintilimab Combined With Bevacizumab in Perioperative Neoadjuvant Chemotherapy for Locally Advanced Low Rectal Cancer

This is a prospective, exploratory clinical study. The primary endpoint of the study is to assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab. The aim is to evaluate the efficacy and safety of sintilimab in combination with bevacizumab in the perioperative neoadjuvant chemotherapy for rectal cancer. The study includes two cohorts: Cohort A involves a retrospective collection of rectal cancer patients who previously received the XELOX regimen in the perioperative setting. Cohort B includes rectal cancer patients undergoing perioperative treatment with sintilimab and bevacizumab combined with XELOX as a neoadjuvant regimen.

Each of the trial group and historical control group requires 59 cases. The administration method for the trial group (Cohort B) is as follows:

Sintilimab: 200 mg, intravenous, Day 1, every 3 weeks. Bevacizumab: 7.5 mg/kg, intravenous, Day 1, every 3 weeks. Chemotherapy regimen: XELOX regimen.

Conditions: Rcctal Cancer
Being tested: sintilimab combined with bevacizumab and XELOX

What participants receive

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

sintilimab combined with bevacizumab and XELOXDrug
Patients with locally advanced low rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvant regimen during the perioperative period.

Study groups in NCT06808412
Study group	Role	What they receive
Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvan	Experimental	Not described Receives: Drug: sintilimab combined with bevacizumab and XELOX

What is being measured

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

assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab
Measured: 1 year

Timeline

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

5 Jul 20245 Jun 2025

First posted5 Feb 2025
Study start5 Jul 2024
Primary completion5 May 2025 (estimated)
Study completion5 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Rcctal 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: 118 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06808412
Sponsor's protocol ID: KY20242241-C-1
Status last verified: Jan 2025
First submitted: 20 Jan 2025
Last updated: 5 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Cremolini C, Antoniotti C, Rossini D, Lonardi S, Loupakis F, Pietrantonio F, Bordonaro R, Latiano TP, Tamburini E, Santini D, Passardi A, Marmorino F, Grande R, Aprile G, Zaniboni A, Murgioni S, Granetto C, Buonadonna A, Moretto R, Corallo S, Cordio S, Antonuzzo L, Tomasello G, Masi G, Ronzoni M, Di Donato S, Carlomagno C, Clavarezza M, Ritorto G, Mambrini A, Roselli M, Cupini S, Mammoliti S, Fenocchio E, Corgna E, Zagonel V, Fontanini G, Ugolini C, Boni L, Falcone A; GONO Foundation Investigators. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2020 Apr;21(4):497-507. doi: 10.1016/S1470-2045(19)30862-9. Epub 2020 Mar 9.
PubMed 32164906
Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.
PubMed 25538173
Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd; Eastern Cooperative Oncology Group Study E3200. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007 Apr 20;25(12):1539-44. doi: 10.1200/JCO.2006.09.6305.
PubMed 17442997
Van Cutsem E, Rivera F, Berry S, Kretzschmar A, Michael M, DiBartolomeo M, Mazier MA, Canon JL, Georgoulias V, Peeters M, Bridgewater J, Cunningham D; First BEAT investigators. Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study. Ann Oncol. 2009 Nov;20(11):1842-7. doi: 10.1093/annonc/mdp233. Epub 2009 Apr 30.
PubMed 19406901
Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.
PubMed 15867200
Chen G, Jin Y, Guan WL, Zhang RX, Xiao WW, Cai PQ, Liu M, Lin JZ, Wang FL, Li C, Quan TT, Xi SY, Zhang HZ, Pan ZZ, Wang F, Xu RH. Neoadjuvant PD-1 blockade with sintilimab in mismatch-repair deficient, locally advanced rectal cancer: an open-label, single-centre phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):422-431. doi: 10.1016/S2468-1253(22)00439-3. Epub 2023 Mar 1.
PubMed 36870360
Wang F, Jin Y, Wang M, Luo HY, Fang WJ, Wang YN, Chen YX, Huang RJ, Guan WL, Li JB, Li YH, Wang FH, Hu XH, Zhang YQ, Qiu MZ, Liu LL, Wang ZX, Ren C, Wang DS, Zhang DS, Wang ZQ, Liao WT, Tian L, Zhao Q, Xu RH. Combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer: a randomized phase 2 trial. Nat Med. 2024 Apr;30(4):1035-1043. doi: 10.1038/s41591-024-02813-1. Epub 2024 Mar 4.
PubMed 38438735
Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.
PubMed 38051328
Molinari C, Passardi A. Why is neoadjuvant chemoradiation therapy underused for locally advanced rectal cancer? Expert Rev Gastroenterol Hepatol. 2016 Dec;10(12):1317-1319. doi: 10.1080/17474124.2016.1246182. Epub 2016 Oct 19. No abstract available.
PubMed 27754713
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Efficacy and Safety of Sintilimab Combined With Bevacizumab in Perioperative Neoadjuvant Chemotherapy for Locally Advanced Low Rectal Cancer
ClinicalTrials.gov ID: NCT06808412
Acronym / sponsor ID: KY20242241-C-1
Conditions: Rcctal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 118 participants (estimated)
Lead sponsor: xiaohua liUniversity, hospital or other
Study start: 5 Jul 2024 (actual)
Primary completion: 5 May 2025 (estimated)
Study completion: 5 Jun 2025 (estimated)
First posted: 5 Feb 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.

Each of the trial group and historical control group requires 59 cases. The administration method for the trial group (Cohort B) is as follows:

Sintilimab: 200 mg, intravenous, Day 1, every 3 weeks. Bevacizumab: 7.5 mg/kg, intravenous, Day 1, every 3 weeks. Chemotherapy regimen: XELOX regimen.

Study design

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

Arm	Type	Receives
Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvan	Experimental	Drug: sintilimab combined with bevacizumab and XELOX

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Cohort A:
Rectal cancer patients who have previously received perioperative XELOX regimen treatment.
Cohort B:
1.Signed written informed consent prior to any trial-related procedures;
2.Non-bedridden cases, regardless of gender, aged 18-75 years;

Key exclusion criteria (28 listed)

5.Experienced active autoimmune diseases requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first administration. Alternative therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;
6.Receiving systemic glucocorticoid treatment within 7 days prior to the first administration of the study (excluding nasal, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy;
Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed;
7.Presence of clinically uncontrollable abdominal effusion (patients who do not require drainage of effusion or who have not shown significant increase in effusion after stopping drainage for 3 days may be included);
8.Known history of allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation;

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
sintilimab combined with bevacizumab and XELOXPatients with locally advanced low rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvant regimen during the perioperative period.	Drug	Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvan

Primary outcome

assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab
Time frame: 1 year

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 5 Feb 2025.
Results publication: PubMed 32164906Cremolini C, Antoniotti C, Rossini D, Lonardi S, Loupakis F, Pietrantonio F, Bordonaro R, Latiano TP, Tamburini E, Santini D, Passardi A, Marmorino F, Grande R, Aprile G, Zaniboni A, Murgioni S, Granetto C, Buonadonna A, Moretto R, Corallo S, Cordio S, Antonuzzo L, Tomasello G, Masi G, Ronzoni M, Di Donato S, Carlomagno C, Clavarezza M, Ritorto G, Mambrini A, Roselli M, Cupini S, Mammoliti S, Fenocchio E, Corgna E, Zagonel V, Fontanini G, Ugolini C, Boni L, Falcone A; GONO Foundation Investigators. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2020 Apr;21(4):497-507. doi: 10.1016/S1470-2045(19)30862-9. Epub 2020 Mar 9.
Results publication: PubMed 25538173Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.
Results publication: PubMed 17442997Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd; Eastern Cooperative Oncology Group Study E3200. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007 Apr 20;25(12):1539-44. doi: 10.1200/JCO.2006.09.6305.
Results publication: PubMed 19406901Van Cutsem E, Rivera F, Berry S, Kretzschmar A, Michael M, DiBartolomeo M, Mazier MA, Canon JL, Georgoulias V, Peeters M, Bridgewater J, Cunningham D; First BEAT investigators. Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study. Ann Oncol. 2009 Nov;20(11):1842-7. doi: 10.1093/annonc/mdp233. Epub 2009 Apr 30.
Results publication: PubMed 15867200Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.
Results publication: PubMed 36870360Chen G, Jin Y, Guan WL, Zhang RX, Xiao WW, Cai PQ, Liu M, Lin JZ, Wang FL, Li C, Quan TT, Xi SY, Zhang HZ, Pan ZZ, Wang F, Xu RH. Neoadjuvant PD-1 blockade with sintilimab in mismatch-repair deficient, locally advanced rectal cancer: an open-label, single-centre phase 2 study. Lancet Gastroenterol Hepatol. 2023 May;8(5):422-431. doi: 10.1016/S2468-1253(22)00439-3. Epub 2023 Mar 1.
Results publication: PubMed 38438735Wang F, Jin Y, Wang M, Luo HY, Fang WJ, Wang YN, Chen YX, Huang RJ, Guan WL, Li JB, Li YH, Wang FH, Hu XH, Zhang YQ, Qiu MZ, Liu LL, Wang ZX, Ren C, Wang DS, Zhang DS, Wang ZQ, Liao WT, Tian L, Zhao Q, Xu RH. Combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer: a randomized phase 2 trial. Nat Med. 2024 Apr;30(4):1035-1043. doi: 10.1038/s41591-024-02813-1. Epub 2024 Mar 4.
Results publication: PubMed 38051328Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.
Results publication: PubMed 27754713Molinari C, Passardi A. Why is neoadjuvant chemoradiation therapy underused for locally advanced rectal cancer? Expert Rev Gastroenterol Hepatol. 2016 Dec;10(12):1317-1319. doi: 10.1080/17474124.2016.1246182. Epub 2016 Oct 19. No abstract available.
Results publication: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Individual participant dataSharing planned: Undecided

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.

wang contact

86-13201793393

wangyannian001@qq.com

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 sintilimab combined with bevacizumab and XELOX in people with Rcctal Cancer, run by xiaohua li 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 22 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. 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 wang (86-13201793393, wangyannian001@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab (time frame: 1 year). 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 NCT06808412, which also lists 10 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 5 Feb 2025.