Ancient Herbal Formula Meets Modern Oncology in Landmark Gastric Cancer Trial

Gastric cancer remains one of the most lethal malignancies worldwide, and for elderly patients the outlook is often even grimmer. After surgery, the risk of recurrence and metastasis looms large, yet many older patients cannot tolerate the aggressive chemotherapy regimens that younger bodies might withstand. Now, a team of Chinese researchers has launched one of the most rigorous tests to date of whether a traditional herbal decoction can help close that dangerous treatment gap. The trial, described in a protocol published in BMC Complementary Medicine and Therapies, will evaluate Yiqi Huayu Jiedu Decoction, a classical Chinese herbal formula, combined with standard chemotherapy to see whether the pairing can prevent postoperative recurrence and metastasis in patients aged 65 and older with stage II or III gastric cancer.

The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial, the gold standard architecture of modern clinical research. It will be conducted across twelve hospitals in China, a scale that lends the investigation considerable statistical and external validity. In total, 302 elderly patients who have undergone D2 resection, the meticulous surgical removal of the stomach along with regional lymph nodes, will be enrolled. Each participant must have pathologically confirmed stage pII or pIII disease, ensuring that the study population reflects the patients who face the highest residual risk after curative-intent surgery. Once enrolled, patients will be randomized in a one-to-one ratio into an experimental group and a control group of 151 participants each.

The experimental arm will receive the herbal decoction alongside chemotherapy for six months, while the control group will receive an indistinguishable placebo with the same chemotherapy. The double-blind design means that neither the patients nor the treating clinicians will know who is receiving the active herbal preparation, a crucial safeguard against the placebo effects and observer bias that have historically undermined studies of traditional medicine. The six-month treatment window is strategically timed to overlap with the postoperative period, when micrometastatic disease, invisible residual cancer cells that have already spread beyond the surgical field, is most vulnerable to systemic therapy.

The primary endpoint of the trial is disease-free survival, a measure of the length of time after treatment during which the patient survives without any signs of cancer returning. Disease-free survival is considered the most clinically meaningful yardstick for adjuvant therapies in solid tumors, because it directly captures whether an intervention actually delays or prevents relapse rather than merely improving surrogate markers. Secondary outcomes include overall survival, the ultimate measure of treatment benefit, as well as the overall chemotherapy completion rate, a particularly important metric in elderly populations where treatment interruptions and dose reductions are common.

Beyond these hard oncological endpoints, the researchers will also track Traditional Chinese Medicine syndrome scores and quality of life assessments, tools designed to quantify the subjective symptoms, fatigue, appetite loss, and general wellbeing that matter enormously to older patients. Safety will be monitored through adverse events graded according to the Common Terminology Criteria for Adverse Events, the internationally standardized vocabulary for describing the severity of treatment side effects. Serious adverse events will be captured as well, ensuring that any added toxicity from the herbal formula is detected promptly and transparently.

What distinguishes this protocol from many previous studies of herbal medicine is its embrace of modern exploratory science. The investigators plan to incorporate big data analytics and assessments of gut microbiota diversity, reflecting a growing recognition that the trillions of microbes inhabiting the digestive tract can influence both cancer progression and chemotherapy efficacy. In gastric cancer, where the organ under treatment is itself a central hub of the digestive system, the interplay between the herbal decoction, the microbiome, and the cytotoxic drugs could prove mechanistically revealing. Subgroup analyses are also planned to explore whether the effects of the decoction vary across patient characteristics, an approach that can uncover heterogeneity that a single average treatment effect would mask.

The clinical problem the trial addresses is genuinely unmet. Elderly gastric cancer patients often tolerate dual-drug chemotherapy poorly, experiencing excessive toxicity that forces dose reductions or complete discontinuation, while monotherapy regimens deliver only limited benefit. This therapeutic bind leaves a large population with high rates of postoperative recurrence and metastasis and few good options. If the herbal decoction can genuinely reduce recurrence while easing the burden of chemotherapy, the implications for geriatric oncology would be substantial, particularly in East Asia where gastric cancer incidence remains among the highest in the world and where traditional medicine is already widely used alongside conventional care.

The trial has cleared the essential regulatory and ethical hurdles that lend credibility to its design. It was approved by the Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine in December 2024, with final approval for the amended protocol granted in August 2025 after two revisions informed by expert recommendations. It is registered with the International Traditional Medicine Clinical Trial Registry, a step that commits the investigators to publishing their methods in advance and reduces the risk of outcome switching, a notorious problem in complementary medicine research. Written informed consent will be obtained from all enrolled patients before any study-related procedures, and the protocol was developed by a broad consortium of oncologists spanning hospitals in Nanjing, Changzhou, Xuzhou, and Jiangyin.

The study is supported by significant national funding, including China’s Noncommunicable Chronic Diseases National Science and Technology Major Project and the National Natural Science Foundation of China, signals that the country’s research establishment is taking integrative oncology seriously. The corresponding author, Peng Shu of the Affiliated Hospital of Nanjing University of Chinese Medicine, leads a team whose affiliations span traditional Chinese medicine institutions and mainstream Western-medicine cancer centers alike, a collaboration model that may prove as important as any single result. Bridging these two medical cultures under the strict discipline of placebo-controlled methodology is precisely what rigorous evaluation of traditional therapies has often lacked.

Caution remains warranted, as it always should be when a trial protocol, rather than completed results, is the subject of discussion. A well-designed protocol guarantees rigor but not efficacy, and the history of complementary medicine is littered with promising hypotheses that dissolved under controlled scrutiny. Yet the stakes of this particular experiment are high and its design is sound. If Yiqi Huayu Jiedu Decoction demonstrates a genuine disease-free survival benefit with acceptable safety, it would represent a rare and consequential example of a classical herbal formula earning a place in evidence-based adjuvant cancer care. If it fails, the trial will still deliver valuable, honest data in a field that badly needs more of it. Either way, the 302 elderly patients who enroll will be contributing to an answer that clinicians and patients around the world have been waiting for.

Subject of Research: A randomized controlled trial of Yiqi Huayu Jiedu Decoction combined with chemotherapy to prevent postoperative recurrence and metastasis in elderly gastric cancer patients

Article Title: Chinese herbal medicine (Yiqi Huayu Jiedu Decoction) combined with chemotherapy for preventing postoperative recurrence and metastasis in elderly gastric cancer patients: protocol for a multicenter, double-blind, randomized, placebo-controlled trial

Article References: Yang, P., Wang, J., Wu, X., Yang, J., Sun, Y., Wei, X., Wu, J., Han, Z., Bi, Y., Zhao, Z., Yang, R., Yang, M., & Shu, P. (2026). Chinese herbal medicine (Yiqi Huayu Jiedu Decoction) combined with chemotherapy for preventing postoperative recurrence and metastasis in elderly gastric cancer patients: protocol for a multicenter, double-blind, randomized, placebo-controlled trial. BMC Complementary Medicine and Therapies. https://doi.org/10.1186/s12906-026-05561-6

Image Credits: AI Generated

DOI: 10.1186/s12906-026-05561-6

Keywords: gastric cancer, Yiqi Huayu Jiedu Decoction, traditional Chinese medicine, randomized controlled trial, chemotherapy, disease-free survival, elderly patients, postoperative recurrence, metastasis, gut microbiota, adjuvant therapy, clinical trial protocol