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

NCT07890324 | Not Yet Recruiting Phase 2

• 1 other identifier: AA0103
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cachexia-Anorexia Syndrome; Cachexia; Cancer

Keywords

Cancer; Cachexia

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline to Week 3 (Day 21)

• 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).

  Baseline to Week 3 (Day 21)

Secondary Outcomes (5)

• Change in quality of life from baseline at Week 3

  Baseline to Week 3 (Day 21)

• Change in dietary intake from baseline at Week 3

  Baseline to Week 3 (Day 21)

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

  Baseline to Week 3 (Day 21)

• Change in pain from baseline at Week 3

  Baseline to Week 3 (Day 21)

• Change in ECOG performance status from baseline at Week 3

  Baseline to Week 3 (Day 21)

Study Arms (3)

4 mg SXRN

EXPERIMENTAL

4 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).

Drug: SXRN Injection

6 mg SXRN

EXPERIMENTAL

6 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).

Drug: SXRN Injection

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

SXRN Injection DRUG

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.

4 mg SXRN

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must meet all the criteria below:
• \. Male or female, aged 18\~75 at the time of signing the ICF;
• \. Histologically or cytologically confirmed advanced malignancy of one of the following: pancreatic cancer; non-small cell lung cancer (NSCLC); colorectal cancer;
• \. 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);
• 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.
• \. 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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• \. Expected survival time ≥12 weeks;
• \. 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.

You may not qualify if:

• Subjects who meet any of the criteria below must not be enrolled:
• \. 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;
• \. 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;
• \. Patients who are only able to receive tube feeding and parenteral nutrition and cannot take oral food intake;
• \. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;
• \. Hormonal therapies judged by the investigator to have effects for improving tumor anorexia-cachexia;
• \. 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.);
• \. 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);
• \. 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;
• \. Patients with central nervous system metastases requiring intervention;
• \. 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.;
• \. History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
• \. (Non-infectious) pulmonary inflammation/interstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;
• \. 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.;

Sponsors & Collaborators

• Jiangsu Guiqiong Pharmaceutical Co., Ltd.: lead
• Jiangsu Nutai Biologics Co., Ltd: collaborator

Study Sites (1)

National Cancer Center/Cancer Hospital

Beijing, China

Location

Related Publications (14)

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• 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.

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  BACKGROUND

MeSH Terms

Conditions

Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

Ning Li

CONTACT

+86 1087788713; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)