AzTrials
AzTrials

Cachexia-Anorexia SyndromePhase 2NCT07890324

A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia

A Phase 2 study testing SXRN Injection in people with Cachexia-Anorexia Syndrome and Cachexia; Cancer, run by Jiangsu Guiqiong Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase II clinical study to evaluate the efficacy and safety of SXRN injection in adult patients with cancer-associated anorexia-cachexia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cachexia-Anorexia Syndrome, Cachexia; Cancer
What is being tested?
SXRN Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteChina
Study dates
Dec 2026to Dec 2027
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

  • The subject must meet all the criteria below:
  • 1. Male or female, aged 18~75 at the time of signing the ICF;
  • 2. Histologically or cytologically confirmed advanced malignancy of one of the following: pancreatic cancer; non-small cell lung cancer (NSCLC); colorectal cancer;
  • 3. Disease status and prior treatment history (meet any one of the following):
  • Pancreatic cancer: Locally advanced (unresectable) or metastatic pancreatic ductal adenocarcinoma, with treatment failure after at least 2 lines of prior systemic anti-tumor therapy (may include gemcitabine, nab-paclitaxel, irinotecan, platinum agents, and fluoropyrimidines);
  • Non-small cell lung cancer (NSCLC): Stage IIIB/IV NSCLC, with treatment failure after at least 2 lines of prior systemic anti-tumor therapy (must include platinum-based chemotherapy; patients with positive driver gene must have received corresponding targeted therapy);
Show all 21Show fewer
  • Colorectal cancer: Metastatic colorectal cancer, with treatment failure after at least 3 lines of prior systemic anti-tumor therapy (must include fluoropyrimidines, oxaliplatin, and irinotecan); patients with MSI-H/dMMR tumors must have received anti-PD-1/PD-L1 therapy followed by treatment failure.
  • 4. Diagnosis of cancer anorexia-cachexia based on the cachexia staging criteria from the 2025 Chinese Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome with consideration of Chinese population characteristics, i.e., satisfying the following criteria (either ①② or ①③):
  • Involuntary weight loss >5% in 6 months; OR weight loss >2% when BMI <18.5 kg/m²; OR weight loss >2% accompanied by muscle mass depletion;
  • Anorexia (VAS score ≤70, or FAACT-A/CS-12 score ≤37);
  • CRP>5 mg/L;
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • 6. Expected survival time ≥12 weeks;
  • 7. Lab results and organ function tested within 7 days before the initial infusion meet the following criteria:
  • Complete Blood Count: Absolute Neutrophil Count (ANC) ≥ 1.0×109/L; Platlets (PLT) Count ≥ 75×109/L; Hemoglobins (Hb) ≥ 80 g/L.
  • Note: Subjects with chronic anemia caused by underlying tumor or cachexia may be enrolled if the investigator assesses the condition as stable; anemia resulting from active bleeding is excluded.
  • Blood Biochemistry: Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft-Gault formula ≥30 mL/min; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; for subjects with concurrent liver metastases, AST and ALT ≤5.0×ULN and ALP ≤6.0×ULN;
  • Blood coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.
  • Note: for subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.
  • Echocardiogram: Left Ventricular Ejection Fraction (LVEF) ≥50%;
  • 8. Subjects are capable of understanding and voluntarily signing the written informed consent form (ICF); subjects must be willing and able to complete study procedures and follow-up assessments.

Who cannot join

  • Subjects who meet any of the criteria below must not be enrolled:
  • 1. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction resulting in patients' inability to eat;
  • 2. Patients who have received any appetite-enhancing or weight-loss-improving medications (including marketed prescription drugs and investigational clinical trial agents) within 28 days before the first study drug administration or 5 half-lives of the drug (whichever is shorter), including but not limited to anamorelin, progestogens such as medroxyprogesterone acetate, cannabinoids, and medical cannabis;
  • 3. Patients who are only able to receive tube feeding and parenteral nutrition and cannot take oral food intake;
  • 4. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;
  • 5. Hormonal therapies judged by the investigator to have effects for improving tumor anorexia-cachexia;
Show all 25Show fewer
  • 6. Patients who have undergone major surgery or interventional procedures within 4 weeks prior to the first dose, or who are scheduled to undergo such procedures during the trial (excluding tumor biopsy, puncture, etc.);
  • 7. Patients with toxicities from previous antitumor therapies that have not yet recovered to ≤ Grade 2 or baseline levels (except for toxicities judged by the investigator as to pose no safety risk, such as alopecia, or asymptomatic hypothyroidism induced by immune checkpoint inhibitors that is stable and only requires thyroid hormone replacement therapy);
  • 8. Clinically uncontrolled serous cavity effusion (pleural effusion, ascites, pericardial effusion): moderate or greater effusion; local therapy (including drainage, peritoneal shunt, cell-free concentrated ascites reinfusion therapy, etc.) within 2 weeks before screening or planned within 2 weeks; significant effusion increase within 2 weeks after local therapy; requirement for long-term indwelling catheter. Subjects meeting any condition or deemed by the investigator unsuitable for enrollment will be excluded;
  • 9. Patients with central nervous system metastases requiring intervention;
  • 10. History of other malignancies, except for those who have undergone curative treatment with no recurrence within 5 years, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, etc.;
  • 11. History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
  • 12. (Non-infectious) pulmonary inflammation/interstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;
  • 13. Subjects with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.;
  • Subjects with New York Heart Association (NYHA) Class III-IV cardiac dysfunction;
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular and cerebrovascular events occurring within 6 months prior to the first study drug administration;
  • 14. Hypertension uncontrolled by a stable regimen of antihypertensive medication (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg);
  • 15. Subjects with active chronic hepatitis B (e.g., HBsAg positive or HBcAb positive with HBV DNA above the lower limit of detection), active hepatitis C (e.g., HCV antibody positive with HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection;
  • 16. Active infection requiring systemic therapy within 2 weeks prior to the first dose;
  • 17. History of active tuberculosis infection within 1 year prior to the first dose;
  • 18. Any other uncontrolled or significant comorbid disease(s), either currently or historically, that by the investigator's judgment may interfere with trial participation or evaluation;
  • 19. Known allergy or contraindication to the investigational product (SXRN injection) or its drug substance process-related impurities (e.g., spectinomycin);
  • 20. For premenopausal female participants (postmenopausal females must be amenorrheic for at least 12 months to be considered of non-childbearing potential): subjects with positive serum pregnancy test, or participants of childbearing potential (including female partners of male participants) who, in the investigator's opinion, are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study and for at least 6 months after the last dose of the study drug;
  • 21. Any other condition that considered by the investigator as to render the patient unsuitable for participation in the study.

Trial locations and contacts

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

Ning Li contact

+86 1087788713

lining@cicams.ac.cn

China1 site

  • National Cancer Center/Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase II clinical study to evaluate the efficacy and safety of SXRN injection in adult patients with cancer-associated anorexia-cachexia. This study comprises a double-blind treatment phase, followed by an open-label treatment phase for eligible participants upon completion of the double-blind period.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase II clinical study designed to evaluate the efficacy and safety of SXRN injection in adult patients with cancer-associated anorexia-cachexia.

Eligible subjects are randomly assigned at a 1:1:1 ratio to one of three treatment arms: Arm A (4 mg SXRN injection), Arm B (6 mg SXRN injection), or Arm C (placebo). During the double-blind treatment phase, study drug or placebo is administered via intravenous infusion once daily for 5 consecutive days followed by a 2-day break, for a total of 3 weeks (21 days). Investigators and participants remain blinded to treatment assignment during this phase.

Upon completion of the double-blind phase, trial participants assessed by the investigator to have no clinical progression or intolerable toxicity will enter the open-label treatment phase and receive a uniform dose of 4 mg SXRN injection. The dosing regimen in the open-label phase is identical to that used in the double-blind phase: 5 consecutive days of dosing followed by a 2-day rest, 21 days per cycle. Subjects continue study treatment until any of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other pre-defined treatment discontinuation criteria, whichever comes first.

Being tested
SXRN Injection, Placebo
Keywords
Cancer, Cachexia
Medical subject headings
Cachexia, Neoplasms

What participants receive

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

  • SXRN InjectionDrug

    4 mg SXRN injection, intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

  • SXRN InjectionDrug

    6 mg SXRN injection, intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

  • PlaceboDrug

    Matching placebo, administered by intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

Study groups in NCT07890324
Study groupRoleWhat they receive
4 mg SXRNExperimental4 mg SXRN injection is administered via intravenous infusion once daily for 5 consecutive days followed by a 2-day break, for a total of 3 weeks (21 days).
Receives: Drug: SXRN Injection
6 mg SXRNExperimental6 mg SXRN injection is administered via intravenous infusion once daily for 5 consecutive days followed by a 2-day break, for a total of 3 weeks (21 days).
Receives: Drug: SXRN Injection
PlaceboPlacebo comparatorPlacebo is administered via intravenous infusion once daily for 5 consecutive days followed by a 2-day break, for a total of 3 weeks (21 days).
Receives: Drug: Placebo

What is being measured

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

  1. Change in anorexia from baseline at Week 3

    Change in anorexia from baseline at Week 3 assessed using the Functional Assessment of Anorexia/Cachexia Therapy-Anorexia/Cachexia Subscale-12 (FAACT-A/CS-12). The scale ranges from 0 to 48. Higher scores indicate better outcome.

    Measured: Baseline to Week 3 (Day 21)

  2. Change in comprehensive physical function from baseline at Week 3

    Change in physical function from baseline at Week 3 assessed using 6-minute walk test (6MWT).

    Measured: Baseline to Week 3 (Day 21)

Secondary outcomes (5)

  1. Change in quality of life from baseline at Week 3

    Change in quality of life from baseline at Week 3 assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score ranges from 0 to 100. Higher scores indicate better outcome.

    Measured: Baseline to Week 3 (Day 21)

  2. Change in dietary intake from baseline at Week 3

    Change in dietary intake from baseline at Week 3 assessed using the Simplified Dietary Self-Assessment Questionnaire. The scale ranges from 1 to 5. Higher scores indicate better outcome.

    Measured: Baseline to Week 3 (Day 21)

  3. Change in body weight/lean body mass (LBM) from baseline at Week 3

    Measured: Baseline to Week 3 (Day 21)

  4. Change in pain from baseline at Week 3

    Change in pain from baseline at Week 3 assessed using the analgesic medication records and the pain domain score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The pain domain score ranges from 0 to 100. Higher scores indicate worse outcome.

    Measured: Baseline to Week 3 (Day 21)

  5. Change in ECOG performance status from baseline at Week 3

    Change in performance status from baseline at Week 3 assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status. Possible grades range from 0 to 5. Lower grades indicate better outcome.

    Measured: Baseline to Week 3 (Day 21)

Timeline

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

  1. First posted22 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890324
Sponsor's protocol ID
AA0103
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

    PubMed 27637832

  • Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

    PubMed 21296615

  • Scherbakov N, Doehner W. Cachexia as a common characteristic in multiple chronic disease. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1189-1191. doi: 10.1002/jcsm.12388. Epub 2019 Jan 13. No abstract available.

    PubMed 30637985

  • Baracos VE, Martin L, Korc M, Guttridge DC, Fearon KCH. Cancer-associated cachexia. Nat Rev Dis Primers. 2018 Jan 18;4:17105. doi: 10.1038/nrdp.2017.105.

    PubMed 29345251

  • Jain R, Handorf E, Khare V, Blau M, Chertock Y, Hall MJ. Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants. Oncologist. 2020 Feb;25(2):161-169. doi: 10.1634/theoncologist.2019-0289. Epub 2019 Nov 20.

    PubMed 32043776

  • Takayama K, Atagi S, Imamura F, Tanaka H, Minato K, Harada T, Katakami N, Yokoyama T, Yoshimori K, Takiguchi Y, Hataji O, Takeda Y, Aoe K, Kim YH, Yokota S, Tabeta H, Tomii K, Ohashi Y, Eguchi K, Watanabe K. Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study. Support Care Cancer. 2016 Aug;24(8):3473-80. doi: 10.1007/s00520-016-3156-8. Epub 2016 Mar 22.

    PubMed 27003901

  • Kimura M, Naito T, Kenmotsu H, Taira T, Wakuda K, Oyakawa T, Hisamatsu Y, Tokito T, Imai H, Akamatsu H, Ono A, Kaira K, Murakami H, Endo M, Mori K, Takahashi T, Yamamoto N. Prognostic impact of cancer cachexia in patients with advanced non-small cell lung cancer. Support Care Cancer. 2015 Jun;23(6):1699-708. doi: 10.1007/s00520-014-2534-3. Epub 2014 Nov 29.

    PubMed 25430482

  • Dev R, Wong A, Hui D, Bruera E. The Evolving Approach to Management of Cancer Cachexia. Oncology (Williston Park). 2017 Jan 15;31(1):23-32.

    PubMed 28090619

  • Anderson LJ, Albrecht ED, Garcia JM. Erratum to: Update on Management of Cancer-Related Cachexia. Curr Oncol Rep. 2017 Mar;19(3):22. doi: 10.1007/s11912-017-0595-4. No abstract available.

    PubMed 28293870

  • Mochamat, Cuhls H, Marinova M, Kaasa S, Stieber C, Conrad R, Radbruch L, Mucke M. A systematic review on the role of vitamins, minerals, proteins, and other supplements for the treatment of cachexia in cancer: a European Palliative Care Research Centre cachexia project. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):25-39. doi: 10.1002/jcsm.12127. Epub 2016 Jul 20.

    PubMed 27897391

  • Zhang H, Garcia JM. Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC. Expert Opin Pharmacother. 2015 Jun;16(8):1245-53. doi: 10.1517/14656566.2015.1041500. Epub 2015 May 6.

    PubMed 25945893

  • Clamon G, Byrne MM, Talbert EE. Inflammation as a Therapeutic Target in Cancer Cachexia. Cancers (Basel). 2022 Oct 26;14(21):5262. doi: 10.3390/cancers14215262.

    PubMed 36358681

  • Gagnon B, Murphy J, Simonyan D, Penafuerte CA, Sirois J, Chasen M, Tremblay ML. Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1041-1053. doi: 10.1002/jcsm.13430. Epub 2024 Mar 13.

    PubMed 38481033

  • Wu D, Jiang Y, Hu X, et al. 2181P A phase I study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of SXRN DNA plasmid in patients with advanced solid tumors Annals of Oncology, 36, S1136-S1137

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SXRN Injection in people with Cachexia-Anorexia Syndrome and Cachexia; Cancer, run by Jiangsu Guiqiong Pharmaceutical Co., Ltd. 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 21 inclusion and 25 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 26 Oct 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. Some participants in this study may receive a placebo. 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 Ning Li (+86 1087788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anorexia from baseline at Week 3 (time frame: Baseline to Week 3 (Day 21)). The study lists 2 primary outcomes in all. 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 NCT07890324, which also lists 14 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 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in